Clearance Summary
THERAPEUTIC STIMULATOR 2100 (TS-2100) received FDA 510(k) clearance under submission number K914904, 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 1992-04-28.
- Submission: K914904
- 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: 1992-04-28
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.