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Thread: Medical device ?

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    Palm Pistol Inventor Calls FDA's Decision 'Political'

    FDA: Firearm For Elderly, Disabled Not A Medical Device

    Last Edited: Wednesday, 10 Dec 2008, 2:28 AM EST

    Created: Wednesday, 10 Dec 2008, 2:28 AM EST







    Should the Palm Pistol be considered a medical device?


    Poll Results:


    By ANTHONY BARTKEWICZ
    MyFoxNational



    Should a gun be considered a medical device? The inventor of the Palm Pistol claims that the Food and Drug Administration said "yes," then changed its mind.

    The Palm Pistol is a single-shot firearm designed for the elderly or disabled who may lack the manual dexterity or strength to fire a regular gun in moments of self-defense. The firing pin is released by pressing a button with the thumb rather than the index finger. (View a diagram of the Palm Pistol mechanism here.)

    The Bureau of Alcohol, Tobacco and Firearms classified it as a standard pistol, but inventor Matthew Carmel wanted to spread the word to senior citizens. So he spoke with the FDA and was advised to register his company as a manufacturer of medical devices and list the pistol as a "daily activity assist device."


    On Monday, the FDA said it had determined the Palm Pistol was "not a medical device," the Associated Press reported.

    Carmel said, "I would assume it's due to political pressure...I most certainly do see this as a Second Amendment issue."

    Carmel explained that seniors and the disabled are at a greater risk of being victims of violent crime while often simultaneously being at an economic disadvantage that leaves them unable to afford firearms for lawful self-defense.

    "If the FDA were to permit my design to be classified as a medical device, at the very least, it may have been possible for seniors and disabled to request partial reimbursement from private health insurance companies," Carmel said in an e-mail interview.


    "I also would have argued that the cost of this adaptive aid should be covered by Medicare. I find it quite ironic that certain elements of the political spectrum demand more protection for the weak, yet when someone steps up to the plate to provide that protection, to empower the weak from predators, they somehow cast a blind eye to their needs," he added.


    A spokesman for Medicare told the Associated Press that the program would not cover the Palm Pistol because there is no approved category for weapons and, as such, "it would not be viewed as reasonable and necessary."

    The Palm Pistol is not yet commercially available, though it is possible to reserve a preorder through the official site. Carmel says he's received "hundreds of e-mails, from all over the world, with inquiries," and that the FDA's decision has no impact on his ability to market the Palm Pistol.

    "Unfortunately," he wrote, "it has a great impact on seniors and the disabled who now may be less able to afford a tool that could be used to lawfully defend their own lives and those of their loved ones."



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    taxwhat wrote:





    Palm Pistol Inventor Calls FDA's Decision 'Political'

    FDA: Firearm For Elderly, Disabled Not A Medical Device

    Last Edited: Wednesday, 10 Dec 2008, 2:28 AM EST

    Created: Wednesday, 10 Dec 2008, 2:28 AM EST







    Should the Palm Pistol be considered a medical device?



    Poll Results:


    By ANTHONY BARTKEWICZ
    MyFoxNational



    Should a gun be considered a medical device? The inventor of the Palm Pistol claims that the Food and Drug Administration said "yes," then changed its mind.

    The Palm Pistol is a single-shot firearm designed for the elderly or disabled who may lack the manual dexterity or strength to fire a regular gun in moments of self-defense. The firing pin is released by pressing a button with the thumb rather than the index finger. (View a diagram of the Palm Pistol mechanism here.)

    The Bureau of Alcohol, Tobacco and Firearms classified it as a standard pistol, but inventor Matthew Carmel wanted to spread the word to senior citizens. So he spoke with the FDA and was advised to register his company as a manufacturer of medical devices and list the pistol as a "daily activity assist device."


    On Monday, the FDA said it had determined the Palm Pistol was "not a medical device," the Associated Press reported.

    Carmel said, "I would assume it's due to political pressure...I most certainly do see this as a Second Amendment issue."

    Carmel explained that seniors and the disabled are at a greater risk of being victims of violent crime while often simultaneously being at an economic disadvantage that leaves them unable to afford firearms for lawful self-defense.

    "If the FDA were to permit my design to be classified as a medical device, at the very least, it may have been possible for seniors and disabled to request partial reimbursement from private health insurance companies," Carmel said in an e-mail interview.


    "I also would have argued that the cost of this adaptive aid should be covered by Medicare. I find it quite ironic that certain elements of the political spectrum demand more protection for the weak, yet when someone steps up to the plate to provide that protection, to empower the weak from predators, they somehow cast a blind eye to their needs," he added.


    A spokesman for Medicare told the Associated Press that the program would not cover the Palm Pistol because there is no approved category for weapons and, as such, "it would not be viewed as reasonable and necessary."

    The Palm Pistol is not yet commercially available, though it is possible to reserve a preorder through the official site. Carmel says he's received "hundreds of e-mails, from all over the world, with inquiries," and that the FDA's decision has no impact on his ability to market the Palm Pistol.

    "Unfortunately," he wrote, "it has a great impact on seniors and the disabled who now may be less able to afford a tool that could be used to lawfully defend their own lives and those of their loved ones."

    If Dr. gave me prescription may I possess in hospital ? Is it OC or CCor Med Carry ?

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    Regular Member Michigander's Avatar
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    Those things are so dumb. I don't see any use beyond suicide for the elderly. You've got a fairly powerful cartridge for the size of that tiny gun which would cause fairly snappy recoil, no real means to aim it beyond some form of point shooting. Flinching with the recoil in addition to no sights would make for some really bad accuracy. It's a one shot deal with no aiming for people that are too geriatric to even be able to handle a .22 High Standard or a similar gun.

    The trigger mechanism is cool, but it needs sights and follow up shots for me to like it.
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    Michigander wrote:
    Those things are so dumb. I don't see any use beyond suicide for the elderly. You've got a fairly powerful cartridge for the size of that tiny gun which would cause fairly snappy recoil, no real means to aim it beyond some form of point shooting. Flinching with the recoil in addition to no sights would make for some really bad accuracy. It's a one shot deal with no aiming for people that are too geriatric to even be able to handle a .22 High Standard or a similar gun.

    The trigger mechanism is cool, but it needs sights and follow up shots for me to like it.
    Shut up! You might discourage this guy and then he won't make them then I won't be able to buy one!

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    Michigander wrote:
    Those things are so dumb. I don't see any use beyond suicide for the elderly. You've got a fairly powerful cartridge for the size of that tiny gun which would cause fairly snappy recoil, no real means to aim it beyond some form of point shooting. Flinching with the recoil in addition to no sights would make for some really bad accuracy. It's a one shot deal with no aiming for people that are too geriatric to even be able to handle a .22 High Standard or a similar gun.

    The trigger mechanism is cool, but it needs sights and follow up shots for me to like it.
    Did you visit their site and look at the ad and design? My Mon has a hard time pulling the trigger on the .22 I got her. This would be a last resort gun at a bed side, stick it in the gut of the attacker and press your thumb down. I would need more info before I bought one for her, but I'm not against the idea.
    An Amazon best seller "MY PARENTS OPEN CARRY" http://www.myparentsopencarry.com/

    *The information contained above is not meant to be legal advice, but is solely intended as a starting point for further research. These are my opinions, if you have further questions it is advisable to seek out an attorney that is well versed in firearm law.

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    Regular Member dougwg's Avatar
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    Cool, optional Laser sight!

    I want one in .40 S&W !

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    Michigander wrote:
    Those things are so dumb. I don't see any use beyond suicide for the elderly. You've got a fairly powerful cartridge for the size of that tiny gun which would cause fairly snappy recoil, no real means to aim it beyond some form of point shooting. Flinching with the recoil in addition to no sights would make for some really bad accuracy. It's a one shot deal with no aiming for people that are too geriatric to even be able to handle a .22 High Standard or a similar gun.

    The trigger mechanism is cool, but it needs sights and follow up shots for me to like it.
    Kinda like a Derringer, Huh? I plan on getting them, assuming they make it to market.

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    I think it is a very cool design, but lets face it, its not a medical device, and should not be paid for by medicare. Also as was said above, it is a powerfull round in a fairly unwieldy design, which will make aiming withouth that laser sight problematic. The lack of a follow up shot is also a problem.

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    Get 2.

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    Venator wrote:
    Did you visit their site and look at the ad and design? My Mon has a hard time pulling the trigger on the .22 I got her. This would be a last resort gun at a bed side, stick it in the gut of the attacker and press your thumb down. I would need more info before I bought one for her, but I'm not against the idea.
    I checked em out. I'm only saying that they need heavier weight, a laser sight or irons, and follow up shots. I applaud the concept of a pistol for the elderly, but I think something so serious deserves a better design. At the age of 22, having been trained in several different unarmed combat styles, and carrying a knife and a baton with me in addition to a gun, I would still hate to have to settle on a single shot 9. Would I settle on my 85 year old grandma's only line of defense being a single shot 9? No way.
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    Regular Member JeffSayers's Avatar
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    That thing is a gun? I thought it was a funny looking tube of toothpaste!
    United we STAND!

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    JeffSayers wrote:
    That thing is a gun? I thought it was a funny looking tube of toothpaste!
    It looks more like an inhaler, I'd hate to get them confused.

    One shot is more than enough foreuthanasia. Which is a growing concern with the elderly.
    An Amazon best seller "MY PARENTS OPEN CARRY" http://www.myparentsopencarry.com/

    *The information contained above is not meant to be legal advice, but is solely intended as a starting point for further research. These are my opinions, if you have further questions it is advisable to seek out an attorney that is well versed in firearm law.

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    Venator wrote:
    JeffSayers wrote:
    That thing is a gun? I thought it was a funny looking tube of toothpaste!
    It looks more like an inhaler, I'd hate to get them confused.

    One shot is more than enough foreuthanasia. Which is a growing concern with the elderly.
    That's probably more of a serious concern that is realized with some elderly...

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    Michigander wrote:
    Venator wrote:
    Did you visit their site and look at the ad and design? My Mon has a hard time pulling the trigger on the .22 I got her. This would be a last resort gun at a bed side, stick it in the gut of the attacker and press your thumb down. I would need more info before I bought one for her, but I'm not against the idea.
    I checked em out. I'm only saying that they need heavier weight, a laser sight or irons, and follow up shots. I applaud the concept of a pistol for the elderly, but I think something so serious deserves a better design. At the age of 22, having been trained in several different unarmed combat styles, and carrying a knife and a baton with me in addition to a gun, I would still hate to have to settle on a single shot 9. Would I settle on my 85 year old grandma's only line of defense being a single shot 9? No way.
    I assume you are LE, for it is illegal to carry a baton, or a knife (greater than 3 inches in length or fixed blade) for self defense purposes. I would rather depend on a single shot pistol than knife or baton at bad breath distances any day. If one is not physically capable of using a 'regular' handgun for self defense, what chance do they really have using a knife or baton?

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    discerningshootist wrote:
    I assume you are LE, for it is illegal to carry a baton, or a knife (greater than 3 inches in length or fixed blade) for self defense purposes. I would rather depend on a single shot pistol than knife or baton at bad breath distances any day. If one is not physically capable of using a 'regular' handgun for self defense, what chance do they really have using a knife or baton?
    There is no state law that states you can't carry a knife over 3". They do have laws on the designs of some knives, like double edged, switchblades, etc. And most of the knife laws are in regards to concealed blades or using it in an illegal way. A person could carry a single edged sword for protection in Michigan.

    But having said the the problem is that many local ordinances prohibit knives carried concealed that are longer than 3". And preemption does not protect knives. So a good rule is don't carry a knife that is shorter than 3" concealed. The gray area is carrying it open in a sheath.

    I'm not sure about a baton, you would need to cite that if you can find it.
    An Amazon best seller "MY PARENTS OPEN CARRY" http://www.myparentsopencarry.com/

    *The information contained above is not meant to be legal advice, but is solely intended as a starting point for further research. These are my opinions, if you have further questions it is advisable to seek out an attorney that is well versed in firearm law.

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    Knives draw blood. Blood in dangerous. That's why I like my ASP.

    Batons, at least the expanding kind, are not mentioned in Michigan law.
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    MCL sections 750.224, 750.226, and 750.227.

    There is one more I remember reading regarding knives and 'bludgeons' but I can't find it. Now there is some gray area.Fixed blade hunting knives are ok, but nothing else can be 'concealed'. OC for swords? Maybe. Also, and I know this is contrary to a free society, but numerous legal opinions regard that any knife with a blade length over 3" is unlawful intent, with the exception of said 'hunting knife'.

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    Regular Member Michigander's Avatar
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    A bludgeon is defined as a short heavy club, usually made of wood. An ASP is long, thin, and made of metal. The laws on clubs are older than the proliferation of expanding batons, so they are not mentioned.
    Answer every question about open carry in Michigan you ever had with one convenient and free book- http://libertyisforeveryone.com/open-carry-resources/

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    I'm sure that's a good legal defense. Besides lead beats long, thin aluminum any day.

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