Monday, December 8, 2008

Prescription Handguns?!?

A little while ago I cam across the Palm Pistol. I did not do a post on it because it did not seem to be anything that special. The Pal Pistol is a single shot weapon that fire 9mm ammo. It appears ergonomically designed with seniors or other people with difficulty in mind. What makes this gun interesting is the classification it received. The FDA has classified the weapon as a Class I Medical Device. Why is this significant; because if their application to the CMS contractor Noridian for a DME is approved a doctor can proscribe the pistol allowing patients to be reimbursed from health insurance company.

"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.

No comments:

Post a Comment

Related Posts with Thumbnails

Like what you read; Subscribe/Fan/Follow