# K963294: Heelbo Wrap Around Vest

- Pathway: 510(k) (Traditional)
- Applicant: Heelbo, Inc.
- Decided: Oct 11, 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 Wrap Around Vest: named in the summary without a submission number

## Indications for use
The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient’s movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails.

Source page: https://510kreport.com/device/K963294
Methodology: https://510kreport.com/methodology