Regulatory and Patent Information

US Food & Drug Administration

NOTE: The products indicated in the FDA’s files are older versions of Alpha-Stim® products. The Alpha-Stim M and Alpha-Stim AID are registered as updates to the original 510(k) applications, and do not appear in the online FDA database.

DOCUMENTATION FOR PAIN INDICATIONS
DOCUMENTATION FOR ANXIETY, DEPRESSION, AND/OR INSOMNIA INDICATIONS

UL Safety Standards Certificate

Canadian Regulatory

Canadian Medical Device Regulations certification

European Regulatory

CE Certification
UL ISO 13485 Certification

Patents

Alpha-Stim Utility Patent 8612008 Dec 17 2013

Ear Clip Patent 8457765 June 4, 2013

PEP Patent 8463406 June 11, 2013

Alpha-Stim Invention Patent for China