# K963091: Vollman Prone Positioner

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: Jan 9, 1997 after 154 days
- Product code: IPT (Orthosis, Thoracic)
- Device class: 1
- Regulation: 21 CFR 890.3490
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stryker Circ-O-lectric Bed Model 460: named in the summary without a submission number
- (no number) Stryker Wedge Turning Frame Model 965: named in the summary without a submission number

## Indications for use
To assist caregivers in turning patients to or from the supine or prone position. Turning immobile patients can assist in treating pulmonary complications or disorders commonly associated with immobility.

Source page: https://510kreport.com/device/K963091
Methodology: https://510kreport.com/methodology