U.S. Regulatory Information

Cranial Electrotherapy Stimulation (CES)
Is cranial electrotherapy stimulation an experimental treatment? No, the FDA does not consider CES experimental.

According to the FDA, cranial electrotherapy stimulator (Regulation No.882.5800) is a grandfathered class III neurological device “…that applies current to a patient’s head to treat insomnia, depression, or anxiety.” Both the Alpha-Stim® 100 and the Alpha-Stim® SCS have been classified as cranial electrotherapy stimulators. The Alpha-Stim® FDA's 510 (k) Premarket Notification Number for these applications is K903014.

Grandfathered class III devices are not considered investigational by the FDA and therefore an Investigational Device Exemption (IDE) is not required for clinical use or research trails with any Alpha-Stim® products or CES devices in general.

Microcurrent Electrical Therapy (MET)
In addition, the FDA has classified the Alpha-Stim® 100 and the Alpha-Stim® PPM as Class II devices for the treatment of acute, chronic and post-operative pain. The Alpha-Stim® 510 (k) Premarket Notification Number for pain applications is K896948. The FDA class II general product definition (Regulation No.882.5890) is: “…a device used to apply an electrical current to electrodes on a patient’s skin to treat pain.”

NOTE: The product indicated in the FDA’s 510(k) database "Alpha-Stim® CS" is an older version of Alpha-Stim® products. The Alpha-Stim® 100 and Alpha-Stim® SCS are registered as updates to the original 510(k) applications so they do not appear in the online FDA database.

Certificate to Foreign Government
UL Safety Standards Certificate

Canada

SGS ISO Certification

European Union

Medical Device Directive Certificate
SGS ISO Certification