# K980640: Heelbo Waist and Chest Vest

- Pathway: 510(k) (Traditional)
- Applicant: Heelbo, Inc.
- Decided: May 1, 1998 after 71 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
Longest line of descent: 1 generation back to K963041 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963099: Heelbo Pullover Poncho and Pullover Poncho with Pocket, Heelbo, Inc. (1996) Summary page 1.
- K963041: Heelbo Life Jacket with Crotch Support, Heelbo, Inc. (1996) Summary page 1.
- (no number) Posey Waist and Chest Vest: named in the summary without a submission number

## Indications for use
The Heelbo Waist and Chest Vest is intended to 1) help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair and 2) help prevent a patient from falling out of bed or climbing over slide rails.

Source page: https://510kreport.com/device/K980640
Methodology: https://510kreport.com/methodology