FDA 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® M and the Alpha-Stim® AID 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 trials with any Alpha-Stim® products or CES devices in general.
6/13/14: the FDA announces their intent to begin the process to down classify cranial electrotherapy stimulation (CES) into Class II! This announcement is the beginning of the conclusion of a 2 decades long struggle with the FDA to appropriately classify CES. The following link is to the June 12 Federal Register notice announcing the withdrawal of their proposal to require Premarket Approval applications be submitted by manufacturers of CES: Federal Register / Vol. 79, No. 113 / Thursday, June 12, 2014
Microcurrent Electrical Therapy (MET)
In addition, the FDA has classified the Alpha-Stim® M as Class II device 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® M and Alpha-Stim® AID are registered as updates to the original 510(k) applications so they do not appear in the online FDA database.