Clearance Summary
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP received FDA 510(k) clearance under submission number K082065, 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 2009-04-10.
- Submission: K082065
- Applicant / Sponsor: Well-Life Healthcare Limited
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2009-04-10
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.