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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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