We recently reported about a new 9mm handgun that was designed for folks suffering from arthritis and other disabilities affecting the hands. Constitution Arms, the manufacturer of the firearm, is reporting that the FDA has formally designated the gun as a medical gadget.
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.”
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.
No word on any futile attempts at a CE Mark of approval for the Palm Pistol in the European Union.
See update to this story here…
FDA Facility Registration and Device Listing confirmation… (.PDF)
Product page: Palm Pistol …
Flashback: A Nine with Ergonomics in Mind
