Clearance Summary
LITRONIC STIMULATOR received FDA 510(k) clearance under submission number K810225, sponsored by Med-Western Electronics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1981-03-30.
- Submission: K810225
- Applicant / Sponsor: Med-Western Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1981-03-30
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.