Clearance Summary
R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213 received FDA 510(k) clearance under submission number K861350, 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: K861350
- Applicant / Sponsor: Tri W-G, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3750
- Decision date: 1986-05-02
Classification & Regulation
This clearance is catalogued under FDA product code INW and 21 CFR 890.3750, within the Physical Medicine review panel as a Class I device.