Clearance Summary
R1596 POWERED EXERCISE EQUIPMENT received FDA 510(k) clearance under submission number K861347, 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: K861347
- Applicant / Sponsor: Tri W-G, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1986-05-02
Classification & Regulation
This clearance is catalogued under FDA product code IOL and 21 CFR 890.5380, within the Physical Medicine review panel as a Class I device.