# K962778: The L-Bow Arm Restraint

- Pathway: 510(k) (Traditional)
- Applicant: Heelbo, Inc.
- Decided: Oct 9, 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.
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) L-Bow Arm Restraint: named in the summary without a submission number

## Indications for use
The L-Bow Arm Restraint fits over the patient’s elbow and is intended to limit the patient’s movement, particularly away from their face and IV tubing, by keeping their arm in an extended position.

Source page: https://510kreport.com/device/K962778
Methodology: https://510kreport.com/methodology