Clearance Summary
TENS PREP received FDA 510(k) clearance under submission number K893604, sponsored by Smith & Nephew United, 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 1989-11-21.
- Submission: K893604
- Applicant / Sponsor: Smith & Nephew United, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1275
- Decision date: 1989-11-21
Classification & Regulation
This clearance is catalogued under FDA product code GYB and 21 CFR 882.1275, within the Neurology review panel as a Class II device.