Regulatory Information
US Food & Drug Administration
Alpha-Stim technology is translated into a variety of easy-to-use
therapeutic devices including the
Alpha-Stim 100 combined microcurrent and cranial electrotherapy stimulator for treatment of
pain, anxiety, depression, insomnia and related disorders. The
Alpha-Stim SCS
treats stress related disorders
such as anxiety, depression and insomnia. The
Alpha-Stim PPM
is designed as a low cost unit for treating pain and comes
only with the self-adhesive AS-Trode™ brand silver
electrodes. All three devices are safe and easy to use and are proven
efficacious through a host of
clinical research,
consumer testimonials
and
professional endorsements.
Replenishable
supplies and accessories are designed to the highest standards to insure
efficacy. For best results, use only Alpha-Stim, AS-Trode™
and Alpha Conducting Solution™ brand supplies for your Alpha-Stim.
Technology is best employed
when the user understands its theoretical basis and proper application.
Therefore, we offer a wide range of educational materials including books and
video and audio tapes.
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.
Premarket Notification for pain,
depression, anxiety and insomnia
UL Safety
Standards Certificate
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