# K963455: Sleeved Jacket/Sleeved Jacket with Slider Control

- Pathway: 510(k) (Traditional)
- Applicant: Skil-Care Corp.
- Decided: Oct 8, 1996 after 35 days
- Product code: KID (Restraint, Wheelchair, Non-Protective)
- Device class: 1
- Regulation: 21 CFR 890.3910
- 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) Sleeved Jacket: named in the summary without a submission number
- (no number) Sleeved Jacket with Slider Control: named in the summary without a submission number

## Indications for use
The sleeved jacket is intended for patients who require posture support while seated in a wheelchair. The sleeved jacket with slider control is intended for patients who require posture support and additional support to prevent sliding forward while seated in a wheelchair. Both are intended for patients who have a history of removing vest-style and poncho-style restraints.

Source page: https://510kreport.com/device/K963455
Methodology: https://510kreport.com/methodology