Clearance Summary
TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED received FDA 510(k) clearance under submission number K924876, sponsored by Graham-Field, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1994-03-01.
- Submission: K924876
- Applicant / Sponsor: Graham-Field, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4800
- Decision date: 1994-03-01
Classification & Regulation
This clearance is catalogued under FDA product code GZT and 21 CFR 882.4800, within the Neurology review panel as a Class II device.