Clearance Summary
MODELS 841,842,843,851,852 & 853 ELEVATING TRACTIO received FDA 510(k) clearance under submission number K844712, 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 1985-03-05.
- Submission: K844712
- Applicant / Sponsor: Tri W-G, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3760
- Decision date: 1985-03-05
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.