Clearance Summary
R1750 AND R1424 POWERED HEATING UNITS received FDA 510(k) clearance under submission number K861340, sponsored by Tri W-G, 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 1986-05-02.
- Submission: K861340
- Applicant / Sponsor: Tri W-G, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5950
- Decision date: 1986-05-02
Classification & Regulation
This clearance is catalogued under FDA product code IRQ and 21 CFR 890.5950, within the Physical Medicine review panel as a Class I device.