Regulatory Information
U.S. 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.
 UL Safety Standards Certificate 219.62 Kb
SGS ISO Certification - Health Canada 177.58 Kb
NOTE: The Alpha-Stim ® SCS is not available in Canada.
European Regulatory
Medical Device Directive Certificate 53.92 Kb
SGS ISO Certification 57.72 Kb
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