# K962834: Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap, and Strap

- Pathway: 510(k) (Traditional)
- Applicant: Heelbo, Inc.
- Decided: Oct 18, 1996 after 88 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 Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap: named in the summary without a submission number

## Indications for use
Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap, and Strap is intended to be a protective limb restraint that limits the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.

Source page: https://510kreport.com/device/K962834
Methodology: https://510kreport.com/methodology