# K963099: Heelbo Pullover Poncho and Pullover Poncho with Pocket

- Pathway: 510(k) (Traditional)
- Applicant: Heelbo, Inc.
- Decided: Nov 1, 1996 after 84 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 Pullover Poncho and Pullover Poncho with Pocket: named in the summary without a submission number

## Most influential descendants
- K980640: Heelbo Waist and Chest Vest (1998), 0 descendants of its own

## Indications for use
The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho’s are also intended to limit the patient’s movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails.

Source page: https://510kreport.com/device/K963099
Methodology: https://510kreport.com/methodology