# K963237: Heelbo Icu 911 Blazer Sleeved Jacket

- Pathway: 510(k) (Traditional)
- Applicant: Heelbo, Inc.
- Decided: Oct 9, 1996 after 51 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) Heelbo ICU 911 Blazer Sleeved Jacket: named in the summary without a submission number

## Indications for use
The Heelbo ICU 911 Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair. The Heelbo ICU 911 Blazer Sleeved Jacket is also intended to limit the patient’s movement while lying in bed to prevent the patient from falling out of bed or climbing over the side rails.

Source page: https://510kreport.com/device/K963237
Methodology: https://510kreport.com/methodology