12-05-2008, 12:57 PM
http://medgadget.com/archives/2008/12/me...dguns.html
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.