Clearance Summary
THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) received FDA 510(k) clearance under submission number K932764, 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 1993-10-01.
- Submission: K932764
- 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: 1993-10-01
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.