SFW · Class I · 21 CFR 876.5984

FDA Product Code SFW: Cranial Electrotherapy Stimulator For Weight Management

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.

Leading manufacturers include Neurovalens Limited.

1
Total
0
Cleared
303d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Cranial Electrotherapy Stimulator For Weight Management Devices (Product Code SFW)

1 devices
1–1 of 1
Not Cleared Oct 17, 2025
Modius Lean
DEN240076
Neurovalens Limited
Gastroenterology & Urology · 303d

About Product Code SFW - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SFW since 2025, with 0 receiving FDA clearance (average review time: 303 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SFW devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →