<H1 class=headline>FDA Lists Handgun for the Handicapped</H1>

Eric Bland, Discovery News

Dec. 8, 2008 -- The U.S. Food and Drug Administration (FDA) has accepted a conceptual, ergonomic 9mm handgun -- designed for people crippled by arthritis, muscular dystrophy, or similar conditions that render them too weak to operate normal handguns -- as a Class 1 Medical Device.

The single-shot gun, dubbed the Palm Pistol, is "an adaptive tool that allows someone otherwise incapable of handling a revolver or semiautomatic weapon to operate one," said Matthew Carmel of Constitution Arms, the New Jersey-based company developing the gun.

Thanks to the gun's designation as a medical device, doctors could eventually write prescriptions for it and then be reimbursed by Medicare.



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The proposed Daily Activity Assist Device (as it is called by the FDA) would be symmetrical, ambidextrous, and made largely of stainless steel.

For the gun to be fired, two mechanical safeties must be depressed with the fingers on either side of the barrel before the trigger, located on the top and bottom of the gun, is pressed by the thumb.

A three-digit combination lock is set opposite to the loading button to help prevent accidental discharge.

The Palm Pistol would hold a single cartridge, loaded by pressing a button in the middle of the combined stock and receiver, which swings to the side.

"A single shot means it's clearly for self-defense," said Carmel. Depending on sales of the single-shot version, he says a multiple-shot version could be possible.

Gun control supporters are not happy about the FDA's decision. Ladd Everitt of the Coalition to Stop Gun Violence was nearly speechless when asked about it.

"This seems like a catastrophically bad decision from the FDA," said Everitt. "A gun is not a medical gadget. It's a tool used to take human life."

Doesn't matter, says Geoffrey S. Clark, the FDA employee who advised Constitution Arms on the listing process.

"This allows someone to do something that a normal person can do," said Clark. "It allows them to overcome some disability to act in a more normal way."

So far about 70 people have committed to buying the $300 Palm Pistol, expected to be available in 2010. Carmel's goal is 200 orders.

"It's both a medical device and a firearm," said Carmel.





Related Links:

Constitution Arms

More on the Palm Pistol

Wow....single shot after the user has to go thru a couple of steps to get the gun prepared to shoot. Sounds like the "dud of the year" gun for handicapped self defense. A good way for the manufacturer to make some $, though.

The device is quite user-friendly in this regard.

Yes, apparently the adaptations for the handicapped person make it user friendly. But , as far as a means of self defense in a real life situation? Questionable, I would say. Fascinating that this gun is considered a "medical device"...a doctor writes out a prescription for a lethal weapon and in the future might be able to get reimbursement from Medicare? Do you see anything wrong with this scenario? These weapons issues get stranger and stranger.....Before you know it, the medical community will be prescribing gun ownership as a means for treating anxieties....

It works for me!

Multiple guns to treat multiple anxieties. A dream come true for the NRA.

The results of this election has caused great anxiety for many of us, and euphoria for the gun dealers. It's a win/win result...

unsolicited & unwanted comment I am sure)-

Dr. Kevorkian is going to come out with a gun for those clinically depressed or with a terminal illness

the "One shot a day keeps the pain & doctors away"

of course, maybe they can follow the advice of the NBA player who "rolled over on his bed onto a knife while cutting an apple" (yeah, sure).

Your correct.

Dear Friends:



The Palm Pistol has been creating quite a stir in the news media. This has been overwhelming and very unexpected.



You may have been following our interactions with the FDA. On December 2, 2008, we were directed by the agency to register our company as a “medical device establishment” and list the Palm Pistol as a “device.” They told us the Palm Pistol would be a Class I Exempt medical device in accordance with 21 CFR 890.5050 Daily Activity Assist Device and would have a product Code ILT. We followed their instructions and completed our registration and listing using their online FURLS system. Once complete, we were informed we were permitted to engage in commercial activities. On December 8, 2008, following wide domestic and international news media coverage of our product, and we can only assume in response to certain political pressures, the FDA cancelled our previously issued establishment registration and device listing, claiming the original action was done in “error.”



This turn of events will have no impact on our plans. Unfortunately the only effect will be upon seniors and disabled. They suffer a disproportionate share of becoming victims of a crime, precisely because they are one of the most weak and vulnerable segments of society. These same people are often at an economic disadvantage and cannot afford to purchase firearms for lawful self-defense. If the FDA had stood by its initial assessment to classified the Palm Pistol 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. We also would have argued that the cost of this adaptive aid should be covered by Medicare. It is 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.



The good news is, with all this unplanned publicity, we are well on our way towards reaching our goal of 200 pre-production reservations. Those of you have so far reserved a Palm Pistol, we owe a debt of gratitude. For those who have not yet taken action, we urge you to do so. While commercial success is certainly an important consideration, we are firm believers in the Second Amendment and the right to self-defense. The Palm Pistol is one small means to make an immediate difference. He who can only do little, is not excused from doing nothing.



Matt Carmel, President

Constitution Arms

973-378-8011

mcarmel@constitutionarms.com

www.palmpistol.com

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NEWS MEDIA LINKS



Fox Red Eye Hosted by Greg Gutfeld, December 8, 2008



http://video.aol.com/video-detail/packing-heat/1848144644/?icid=VIDLRVNWS04

Fox News with Bill Hemmer, Tuesday December 9, 2008

http://www.foxnews.com/video-search/m/21619421/medical_device.htm?q=palm

Fox Channel’s The Strategy Room, Tuesday December 9, 2008

http://www.foxnews.com/video-search/m/21620974/prescription_pistol.htm?pageid=23059

AP Press Release by Ricardo Alonzo-Zaldivar, Tuesday December 9, 2008

http://www.google.com/hostednews/ap/article/ALeqM5gX8fvj4MkM30m7rPfghQ_INA2qfgD94UQUEG1

MyFox Colorado by Anthony Bartkewicz, Wednesday December 10, 2008

http://www.myfoxcolorado.com/myfox/pages/Home/Detail?contentId=8037658&version=1&locale=EN-US&layoutCode=TSTY&pageId=1.1.1&sflg=1

The Tonight Show with Jay Leno, Thursday December 11, 2008 at time mark 9:00

http://www.nbc.com/The_Tonight_Show_with_Jay_Leno/video/episodes/#vid=878941

New York Post Editorial by Adam Brodsky, Friday December 12, 2008

http://www.nypost.com/seven/12122008/postopinion/opedcolumnists/take_two_bullets__call_me_in_the_morning_143734.htm

I certainly admire the spirit of entrepreneurship..identify a need...design a product....market that product. But, to take advantage of the elderly and disabled by playing to their vulnerabilities as a means to sell the product AND to add insult to injury, to try to have insurance companies pay for the guns as "medical devices" is nothing more than someone trying to make a buck off of the old, the disabled and the insurance companies. At least the FDA didn't fall for this "scam".....

Certainly, the reality of this palm pistol being able to afford anyone real protection, in a real life situation, is a joke. But, of course there are always those who will prey on the vulnerable and those who will allow themselves to become their "victims".

Please, amy...Enlighten me with your defensive weapons expertise.
The single shot and double shot derringer pistol has been with us for over 200 years, and has proved it's effectiveness many times over.

I defer to your expertise in this area .....however, maybe you could offer up a real life situation where this type of self defense gun would get the job done. When I envision a threatening situation in the home, I can't imagine that this gun would be much of a deterrent, any way I look at it. Ditto for a "mugging" situation on the street. Those who intend harm don't offer up neat, predictable scenarios that would allow the intended victims to respond in a way that could prevent the crime. Here I go again, the broken record....
without serious training in how to use a weapon for self-defense, I believe there is great potential for armed people to do themselves more harm than good.....and to potentially do harm to others that are not out to victimize them.
Guns don't kill, people who use guns kill. "Mandated training for gun owners can save lives." "With freedom comes rseponsibility". These should be the NRA mottos.

Training is always indicated in the use of a handgun of any type, but any weapon in hand is better than nothing, wouldn't you say? It is not the first line of defense, rather the last. No guarantees here.

If you were home alone amy and a man was breaking into your home intent to do you harm, how would you deal with it?

Well, actually I've given this scenario some serious consideration. Questions I ask myself and my conclusions:

1. What if there is more than one intruder?

2. What if the intruder(s) is (are) in our bedroom or my son's bedroom?

3. If I owned a weapon for self defense, which type would likely be the most effective for me to use?

4. Where would I keep the weapon(s)?One for my bedroom, one for downstairs one for the basement rec room? An intruder isn't going to let me know where and when he/she plans on entering my home.

5. Do I have the gun on my person at all times?If I really want to protect myself and my family, that would be the obvious answer.

6. How would I handle a person attacking me from behind?.A gun won't be of help, but other self defense maneuvers might....

7.Would owning a gun for self defense give me a false sense of confidence since not every situation would lend itself to using a gun to protect myself....

8. 'Real life' encounters with criminals is a lot messier than how it is portrayed on tv....

Seems to me that I should carry something on my person and in my car that could "disable" and attacker.....something that could be sprayed in the face....I don't know...I'm still thinking......a mini fire extinguisher sounds good to me......maybe a shotgun for the home....if the situation allowed....point and shoot, if necessary.

Very good...I'm impressed. The first thing is to look around to see what deterrents you already have in place. Alarm systems, proper locks, a dog for early warning, etc. Find out the elapse time for police in your area on 911 calls.
If a gun isn't to your liking, Non-lethals or less lethals such as sprays or personal tasers are available. A short-barreled shotgun is the best home defense weapon. It is also the safest in the respect that the projectiles are less likely to penetrate a wall and injure an innocent.

And, here we have the latest in tattoo fashion for all those cowgirls out there.

I don't have a tatoo, never had a woman who had one...
but earth-women entice me...totally different sort.
Earth-mothers and Ink-mothers...one lives the life,
the other buys some art, I seek the comfort of the first.

You can't buy motherhood, you must suffer the right.
But then, I feel the same about soldies of war.
Men have war, women birth...BWTF do I know.

Well, in truth, some women "suffer" motherhood and war....some men, only war.