

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.
The Alpha-Stim® SCS is not available in Canada
Both the ALPHA-STIM 100 and ALPHA-STIM SCS (Stress Control System) treat anxiety, depression and insomnia. The ALPHA-STIM 100 also treats acute, chronic, and postoperative pain and the ALPHA-STIM PPM (Personal Pain Manager) is designed as an alternative to TENS for localized treatment of pain. The primary distinctive feature in a medical device is the waveform, and ALPHA-STIM has a uniquely effective waveform. The application of direct electrical treatment to the brain, along with our treatment protocols for pain also makes the difference that no other device has been able to emulate. Further, ALPHA-STIM technology has been shown to be far more cost effective than prescription drugs.


