Clearance Summary
Well-Life Garment Electrodes (GM Series) received FDA 510(k) clearance under submission number K200942, sponsored by Well-Life Healthcare Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2021-06-01.
- Submission: K200942
- Applicant / Sponsor: Well-Life Healthcare Limited
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2021-06-01
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.