FDA Registration Record for Palm Pistol as an Approved Medical Device

Palm Pistol Specification

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The Food and Drug Administration (FDA) has completed its “Device/Not a Device” determination and ruled the pistol will be listed as a Class I Medical Device, exempt from 510(k) Pre-Market Notification, in accordance with and subject to 21 CFR 890.5050 “Daily Activity Assist Device.”

An effort is underway to obtain Center for Medicare and Medicaid Services (CMS) Durable Medical Equipment (DME) coding for the Palm Pistol. DME is defined under federal law as equipment that is capable of withstanding repeated use, is primarily used to serve a medical purpose, generally is not useful to an individual in the absence of an illness or injury, and is appropriate for use in the home.  We argue the pistol meets this definition in that is can withstand repeated use, the medical purpose served is extension of life expectancy, all living individuals are subject to the “injury” of shortened life expectancy due to loss of life from criminal assault and it most assuredly is appropriate for use in the home.  An additional function of the device is prevention of sudden onset death, analogous to the benefits offered by on-body alarm systems which permit independent unassisted living without the need for Certified Nursing Assistants. If we are successful in obtaining DME coding, it is possible the medically prescribed purchase of the Palm Pistol will be reimbursable by Medicare or private health insurance companies for qualified insured’s.

Medical indications for use include but are not limited to arthritis; peripheral neuropathy caused by chemotherapy, infection, traumatic injury or diabetes; phalangeal amputations/fusions/fractures; distal muscular dystrophy; multiple sclerosis, carpal tunnel syndrome, Raynaud’s syndrome; ganglion cysts; side effects of certain medications; and inclusion body myositis.