# K961437: Wheeled Stretcher

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: Jun 3, 1996 after 49 days
- Product code: FPO (Stretcher, Wheeled)
- Device class: 2
- Regulation: 21 CFR 880.6910
- 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 "Synergy Series" Stretchers: named in the summary without a submission number

## Indications for use
The subject stretcher and predicate are intended to be used with the general population to transport patients and to allow for patient care before, during, and after transport. The stretchers may be used in or for various patient care facilities and departments including, but not limited to, ED, transport, PACU, ambulatory surgery, long term care and home care. When fitted with the optional radiolucent surface, the stretcher may be used for acquisition of radiographic images.

Source page: https://510kreport.com/device/K961437
Methodology: https://510kreport.com/methodology