# K963569: Wheelchair Waist Belt, Medline Economy Wheelchair Belt, Medline Two-Piece Safety Soft Belt, Medline Wheelchair Belt with

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Oct 18, 1996 after 43 days
- Product code: FMQ (Restraint, Protective)
- Device class: 1
- Regulation: 21 CFR 880.6760
- 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 no predicate by number.

## Indications for use
Medline Wheelchair Safety Belt Restraints are intended for use with patients or residents that need a “gentle reminder” for the patient to stay in their wheelchair or to remind them to seek assistance before standing. These products are also intended to help prevent falls or to help the patient feel safer in their wheelchair. Several of the designs are intended to enable the user to release them, per O.B.R.A. regulations. These products are designed for use with a carefully defined medical treatment program which addresses (but is not limited to) restorative nursing, patient release, and pressure sore prevention. Aggressive, agitated or restless patients require increased monitoring and a systematic review and evaluation of both their physical and psychological status. Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, for patients that are at risk for a life threating fall or fall that may cause serious injury or re-injury, or to help patients feel safer in wheelchair. Medline Wheelchair Safety Belt Restraints are not intended for use with stretchers, on toilets or shower chairs or in the shower or tub. Medline Patient Safety Products are not intended for use in a motorized vehicle, as they are not designed to withstand the force of a crash. Medline Patient Safety Products are not intended for home use. These devices are for use in hospitals and/or nursing homes to help maximize patient safety and are not intended to preclude good nursing care and common sense.

Source page: https://510kreport.com/device/K963569
Methodology: https://510kreport.com/methodology