As long as they call it a gun, market it as a gun, and understand that everyone that buys one treats it like a gun that's fine. It is not, however, a medical device. It looks like at least half the reason for this gun is market penetration rather than self defense.
Your average gun is really, really easy to operate. If the target market for this product can't handle a small semi auto or revolver, at least a fair number of them won't have the reaction time, situational awareness, or motor skills to use it correctly. It looks like this guy just trying to figure out a way to get health insurance to pay for his gun. If your legs don't work you can't run from the bad guy and you need a gun. But if your eyes aren't so good and your hands don't work so good and your cognitive skills aren't so good, you don't need a gun, you need an armed caregiver.
In a statement to medGadget Carmel said: “Based upon agency information, correspondence, and verbal instructions, we were led to believe the Palm Pistol was classified as a ‘device,’ were given specific listing instructions, assigned Product Code ILT corresponding with ‘Recreational Adapter’ and identification of the device as a ‘Daily Activity Assist Device’ in accordance with 21 CFR 890.5050, and accordingly informed we had authority to begin marketing it as such a ‘device.’
Unless the elderly customer targeted by this marketing ploy's daily recreational activities include armed conflict intervention, they need to call it a gun and sell it as such. Let it compete in the firearms market with all the other pocket and purse size firearms out there.