Clearance Summary
THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) received FDA 510(k) clearance under submission number K932399, sponsored by Myo/Kinetic Systems, 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 1993-08-11.
- Submission: K932399
- Applicant / Sponsor: Myo/Kinetic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1993-08-11
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.