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
UL Safety Standards Certificate
SGS ISO Certification (Health Canada) The Alpha-Stim® SCS is not available in Canada
European Regulatory
SGS Canada
Medical Device Directive Certificate
SGS ISO Certification
