# K963454: Cushion Belt/Cushion Slider Belt/Adjusta-Loop Cushion Belt/Quick Release Cushion Belt

- Pathway: 510(k) (Traditional)
- Applicant: Skil-Care Corp.
- Decided: Oct 7, 1996 after 34 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 its predicate without a number.
- (no number) Cushion Belt: named in the summary without a submission number
- (no number) Cushion Slider Belt: named in the summary without a submission number
- (no number) Adjusta-Loop Cushion Belt: named in the summary without a submission number
- (no number) Quick-Release Cushion Belt: named in the summary without a submission number

## Indications for use
The Cushion Belt is intended for patients who require a safety belt when in the wheelchair or bed. It is also used as a reminder not to leave the wheelchair or bed without assistance. The Cushion Slider Belt is intended for patients who require a safety belt while in the wheelchair and who also need added control to prevent sliding down in the wheelchair. The Adjusta-Loop Cushion Belt is intended for patients who require a safety belt while in the wheelchair and who require a reminder not to leave the wheelchair without assistance. The Quick-Release Cushion Belt is intended for patients who require a safety belt while in the wheelchair and who require a reminder not to leave the wheelchair without assistance.

Source page: https://510kreport.com/device/K963454
Methodology: https://510kreport.com/methodology