# Cranial Electrotherapy Stimulator For Weight Management
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SFW)
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