Clearance Summary
THERA-TRONIC THERAPEUTIC TREATMENT TABLE received FDA 510(k) clearance under submission number K852651, sponsored by Rwm Co.. 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 1985-09-30.
- Submission: K852651
- Applicant / Sponsor: Rwm Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3760
- Decision date: 1985-09-30
Classification & Regulation
This clearance is catalogued under FDA product code INQ and 21 CFR 890.3760, within the Physical Medicine review panel as a Class I device.