FDA Certifies Handgun as "Medical Device"

by jordan | December 4, 2008 at 02:04 pm

431 views | 18 Recommendations | 7 comments

UPDATE: The FDA has now retracted their classification of The Palm Pistol as a medical device.


The single-bullet Palm Pistol set the Internet abuzz with speculation that Medicare might even pay for the elderly and disabled to pack heat.

But Monday the Food and Drug Administration said the Palm Pistol doesn't have a shot of being listed as a medical device, and revoked the registration issued to its inventor only last week.

"The FDA has determined the product is not a medical device," the agency said in a statement.

The inventor is crying foul. "I would assume it's due to political pressure," said Matthew M. Carmel, from Maplewood, N.J. He said he's researching a possible appeal.

Original story from December 4:

I just read on Slashdot that the  US Food and Drug Administration (FDA) has concluded that the Palm Pistol (see below) can be prescribed  as a medical device.

The Palm Pistol is a handgun made for those who are physically unable to wield a normal pistol, which one would presume should contraindicate handing their being handed a gun in the first place, for the obvious safety reasons.

As for the "it's a deterrent" argument, the device (via links below) looks nothing whatsoever like a gun, and therefore would not be scary.

Remember the Palm Pistol ergonomic handgun from a few months back? Well, you will be interested to know that it has been designated as a medical gadget by the FDA.
Thanks to the Second Amendment, even the elderly have the right to keep and bear arms. The problem is that many of the guns out there are a bit unwieldy for an older person to handle. However, the inventors of the Palm Pistol are planning to change all that with a weapon that is ideal for both the elderly and the physically disabled. The firearm appears to be a redesign of the classic "Chicago Palm Pistol" first patented in the US in 1883—the difference being that the modern Palm Pistol is a single shot device with a thumb trigger.

Constitution Arms contacted us with the following information:

Several weeks ago you were kind enough to blog about the Palm Pistol. We thought you might be interested to learn that the FDA has completed its “Device/Not a Device” determination and concluded the handgun will be listed as a Class I Medical Device, exempt from 510(k) Pre-Market Notification in accordance with 21 CFR 890.5050 “Daily Activity Assist Device.”


Looking at the picture, it's triggered by the same hand motion that would be used in picking it up. Uh-oh.

Also, why would it need a medical certification, unless one hoped to get it covered by medical insurance?

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Terri Potratz

Sorry, but that is just wrong...that's like giving elderly scooters the capability to go 55 mph, you just don't do that...

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Emilio Lizardo

Stranger than fiction, Jordan !

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Jon Azpiri

I guess the NRA is right: guns really don't kill people. They heal people.

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Rhonda J Mangus

Brilliant! Thanks for this story, Jordan.

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Blue Crush

Insane!  Cute... but insane!

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jdberger

None of those pics are of the FDA approved palm pistol.

It's NOT triggered by the same motion that you would use picking it up. It has two safeties that need to be disengaged with a firm grip and then must be fired by depressing the thumb.

Terri? Since when are the elderly/handicapped less deserving of self defense? Are you really suggesting that Grandpa who fought overseas in WWII for this country shouldn't be allowed to defend himself because he's old?

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Terri Potratz

My feelings on elderly people with guns are the same as my feelings towards elderly people with vehicles; if you can pass vision/cognitive/hearing tests, then you can keep privileges - such as driving and firing a weapon - that require all of those senses.  I think these tests should be a requirement once a year for anyone over 60 - both for the safety of the individual, and the rest of the community.  Last thing we need is a 70 year old suffering from dementia roaming the streets and waving a single-shot pistol out their car window.

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December 4, 2008 at 02:04 pm by jordan, 431 views, 7 comments

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