This is a prescription for trouble. A new gun has been developed specifically to be be fired by people who are elderly or handicapped.
Grimly, I can envision more than one potential application for a device like this, but via prescription?
…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.”
We have now submitted an application to the CMS contractor Noridian for a DME (Durable Medical Equipment) Coding Verification in order to be assigned an HCPCS code. Once assigned , physicians will be able to prescribe the Palm Pistol for qualified patients who may seek reimbursement through Medicare or private health insurance companies.
Weird. Why can’t they buy it like anyone else buys a gun? What am I missing here?
Yeah, this is a medical device, alright. Someone will need medical attention immediately after using it.