Clearance Summary
LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR received FDA 510(k) clearance under submission number K910616, sponsored by Life Balance Intl., 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 1992-05-12.
- Submission: K910616
- Applicant / Sponsor: Life Balance Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5800
- Decision date: 1992-05-12
Classification & Regulation
This clearance is catalogued under FDA product code QJQ and 21 CFR 882.5800, within the Neurology review panel as a Class II device.