# K012616: Clearmedical/Huntleigh Foot Garments; Models FG200/LRG (Large), FG200/STD (Standard), FG100/SM (Small), FG100-R (Regular

- Pathway: 510(k) (Traditional)
- Applicant: Clearmedical, Inc.
- Decided: Feb 6, 2002 after 177 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- 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) Huntleigh Foot Garments (FG200-LRG, FG200-STD, FG100-SM, FG100-R): named in the summary without a submission number

## Indications for use
Prevention of deep vein thrombosis. Enhancement of venous and arterial circulation. Prevention of venous stasis. Assist in healing of cutaneous ulcers, including venous stasis ulcers. Reduction of acute and chronic edema. Reduction of lower limb pain due to trauma or surgery. Reduction of compartmental pressures.

Source page: https://510kreport.com/device/K012616
Methodology: https://510kreport.com/methodology