FDA Cancelling The Registration Of Handgun For The Disabled

By Alice Carver
14:10, December 9th 2008
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FDA Cancelling The Registration Of Handgun For The Disabled

The US Food and Drug Administration has revoked the registration for the single-bullet Palm Pistol designed for people disabled by arthritis. “The FDA has determined the product is not a medical device,” the agency said in a statement.

The handgun was initially registered as a medical device, but on Monday the Food and Drug Administration decided to cancel the registration of the product in its electronic database. The agency has determined the Palm Pistol, manufactured by Constitution Arms, is not a medical device under the Federal Food, Drugs, and Cosmetic Act.

The New Jersey company that makes the product applied for FDA approval as a “Daily Activity Assist Device.” Matthew M. Carmel, from Maplewood, New Jersey, said the company is searching for a possible appeal.

He said that the elderly and disabled may be victims for criminals and the Palm Pistol could help them. Shaped like an oval, it fits in your palm. And instead of pulling a trigger, the device allows individuals to shoot by squeezing with their thumb, according to the manufacturer.

The company says the device is ideal for seniors, disabled and others who may have limited strength or manual dexterity and who would otherwise have trouble pulling the trigger. The single shot pistol is being sold for $300 as a “defensive firearm” home defense.

Medicare, however, would have never approved guns for the elderly anyway. Medicare’s spokesman explained that the health care program will not cover the product because there is no approved category for weapons.



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