FDA product code SFW: Cranial Electrotherapy Stimulator For Weight Management
SFW is the FDA product code for cranial electrotherapy stimulator for weight management. It is a Class I device, regulated under 21 CFR 876.5984 and reviewed by the Gastroenterology and Urology panel. Devices under SFW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cranial Electrotherapy Stimulator For Weight Management |
| Device class | Class I |
| Regulation | 21 CFR 876.5984 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for SFW devices
openFDA lists no recalls for product code SFW.
Frequently asked questions
What is FDA product code SFW?
SFW is the FDA product code for cranial electrotherapy stimulator for weight management. It is a Class I device, regulated under 21 CFR 876.5984 and reviewed by the Gastroenterology and Urology panel.
What device class is SFW?
Class I, regulation 21 CFR 876.5984. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SFW
- Run a recall and safety report across every SFW manufacturer
- Watch product code SFW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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