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"Palm pistol" may get approved for Medicare and medical insurance
That's big news!
Matt Carmel is, well, an inventive fellow. He designed a gun for self-defense by the handicapped who can't handle a regular gun, patented it, designed it around ATF's definition of "any other weapon," so that they classified it as an ordinary handgun, and now got the FDA to list it as as "medical device." The last means that a physician can prescribe it. His next move is to become a designated Medicare equipment supplier, and then move on to private insurers.
UPDATE: it's covered, in an article at med-gadgets.com.
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However, does this mean that you need a prescription to buy it?
mr. Carmel might be getting just a little bit too clever, i'm worried. somehow i doubt the ATF will very much agree with classifying a gun as a "medical device", and once the FDA really realizes what they've gone and done, their top guys probably won't like it any better.
As a Freelance Writer, I was contacted by Matt Carmel after an article I had done on the problems experienced by the disabled in shooting traditional firearms was published in Concealed Carry Magazine. I’ve been following his battle with the government trying to get his product licensed as a medical device. I love people who march to the beat of a different drummer. [email protected]
Does BATF have jurisdiction over medical devices? Is a 4473 necessary?
One could easily make the argument that all handguns meant for defensive use are medical devices - they are designed specifically with the purpose of punching holes in human beings.
Other questions: If one gets a prescription for a palm pistol from a doctor, can BATF say "no, you can't have it" because the now 85 y.o. patient did a felony 60 years before? Can BATF or a state delay the delivery of a medical device?
Why didn't they copy the Chicago Palm Pistol and make it a 5 or 6 shot instead of a single shot?
The design of the Chicago Palm Pistol is very simple. With modern materials a 9mm or a 38 short would have been easy.
I didn't make it a multi-shot device because combining a semi-auto with the unique design and exterior threaded barrel would likely get it banned in many states, in spsite of the ATF ruling it is a standard "pistol." A single shot firearm is clearly self-defensive.
I woould also like to clear up some misconceptions taht are being published by the anti-gun news media. The FDA does not approve anything just like OSHA does not approve ladders. My company is now an FDA "Registered Medical Device Facility" and the Palm Pistol is "Listed" as a Class I Medical Device, exempt from a 510(k) Pre-Marketing Notification.
The FDA doesn't make a determination about a weapon, they make a determination about medical products that are designed to help people and improve their health, and my device clearly does that. It has been listed in conformance with 21 CFR 890.5050 "Daily Activity Assist Device."
Contrary to what you may have read, I have never made any statement,implication or suggestion that my device is "approved" by FDA or any other agency. The FSA has simply determined my device meets the definition of "Daily Activity Assist Device" in accordance with the CFR and must be marketed subject to those restrictions established for that device.
There is no guarantee that Medicare or private health insurance companies will reimburse for this but I am sure as heck going to try.
I think this is a neet idea. We all should be thinking about "self" defence instead of waiting for the police to save you. Now you can assist the police, create a trail to the hospital. You have the right to defend your self period!
[email protected]
I've heard of people who concealed carry telling people "it's a medical device" when questioned about the bulge under their shirts. Now it really is!