Clearance Summary
ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A received FDA 510(k) clearance under submission number K905571, sponsored by Biomedical Life Systems, 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 1991-05-08.
- Submission: K905571
- Applicant / Sponsor: Biomedical Life Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1991-05-08
Classification & Regulation
This clearance is catalogued under FDA product code LIH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.