Cranial Electrotherapy Stimulator For Weight Management
SFW · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5984
Classification
FDA Product Code
SFW
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 876.5984
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A cranial electrotherapy stimulator for weight management is a battery-powered device that applies electrical current to a patient's head through electrodes placed on the skin to support weight management in conjunction with diet and exercise. Devices in this classification use a low level of electrical current that is not intended to induce a seizure.