Clearance Summary
MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC received FDA 510(k) clearance under submission number K902976, sponsored by Medical Consultants Intl. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1990-09-07.
- Submission: K902976
- Applicant / Sponsor: Medical Consultants Intl. , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1330
- Decision date: 1990-09-07
Classification & Regulation
This clearance is catalogued under FDA product code GZL and 21 CFR 882.1330, within the Neurology review panel as a Class II device.