Clearance Summary
MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT received FDA 510(k) clearance under submission number K861864, sponsored by I-Rep, 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 1986-07-14.
- Submission: K861864
- Applicant / Sponsor: I-Rep, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5290
- Decision date: 1986-07-14
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.