# K963378: Medline Economy Limb Holder,Deluxe Limb Holder,Cinch-Type Limb Holder,Padded Limb Holder,Adjustable Limb Holder

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Oct 29, 1996 after 63 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 no predicate by number.

## Indications for use
Medline’s Limb holders are intended to be utilized as a patient safety device when limited movement of the limb is deemed necessary.

Source page: https://510kreport.com/device/K963378
Methodology: https://510kreport.com/methodology