Clearance Summary
TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 received FDA 510(k) clearance under submission number K881211, 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 1988-05-11.
- Submission: K881211
- Applicant / Sponsor: Tru-Trac Therapy Products, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 1988-05-11
Classification & Regulation
This clearance is catalogued under FDA product code IMI and 21 CFR 890.5300, within the Physical Medicine review panel as a Class II device.