Regulatory Information

US Food & Drug Administration

NOTE: The products indicated in the FDA's files are older versions of Alpha-Stim products. The Alpha-Stim 100 and Alpha-Stim SCS are registered as updates to the original 510(k) applications so they don't appear in the online FDA database.

Documentation for pain indications

Documentation for anxiety, depression and/or insomnia indications

Certificate to Foreign Government

UL Safety Standards Certificate

SGS ISO Certification (Health Canada) The Alpha-Stim ® SCS is not available in Canada

European Regulatory

Medical Device Directive Certificate

SGS ISO Certification