Clearance Summary
VOLLMAN PRONE POSITIONER received FDA 510(k) clearance under submission number K963091, sponsored by Hill-Rom, 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 1997-01-09.
- Submission: K963091
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3490
- Decision date: 1997-01-09
Classification & Regulation
This clearance is catalogued under FDA product code IPT and 21 CFR 890.3490, within the Physical Medicine review panel as a Class I device.