# K963457: Sleeper Jacket/Houdini Safety Sleeper

- Pathway: 510(k) (Traditional)
- Applicant: Skil-Care Corp.
- Decided: Oct 9, 1996 after 36 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) Sleeper Jacket: named in the summary without a submission number
- (no number) Houdini Safety Sleeper: named in the summary without a submission number

## Indications for use
The Sleeper Jacket and the Houdini Safety Sleeper are intended for patients who require restraint while in bed or in the wheelchair and who easily remove standard vest-style and poncho-style restraints. The Houdini Safety Sleeper is recommended for patients who slide or move toward the foot of the bed or who slide off the wheelchair seat.

Source page: https://510kreport.com/device/K963457
Methodology: https://510kreport.com/methodology