Clearance Summary
TRU-SOUND ULTRASOUND THERAPY UNIT received FDA 510(k) clearance under submission number K871633, sponsored by Tru-Trac Therapy Products, 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 1987-05-28.
- Submission: K871633
- Applicant / Sponsor: Tru-Trac Therapy Products, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5290
- Decision date: 1987-05-28
Classification & Regulation
This clearance is catalogued under FDA product code IMJ and 21 CFR 890.5290, within the Physical Medicine review panel as a Class II device.