Clearance Summary
PRONE POSITIONER received FDA 510(k) clearance under submission number K932187, sponsored by Voss Medical Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1993-06-01.
- Submission: K932187
- Applicant / Sponsor: Voss Medical Products
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1993-06-01
Classification & Regulation
This clearance is catalogued under FDA product code KIL and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.