# K052243: Proact with Gel or Proact 1

- Pathway: 510(k) (Traditional)
- Applicant: Proact, Inc.
- Decided: Apr 12, 2006 after 238 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
Longest line of descent: 1 generation back to K003909 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003909: Proact 1, Proact Co. (2001) Summary page 1.

## Indications for use
The ProAct with Gel is a prescriptive device indicated for: * Lymphedema - primary and secondary * Prevention of venous stasis * Prevention of Deep Vein Thrombosis (DVT) * Edema following trauma and sports injuries * Post immobilization edema

Source page: https://510kreport.com/device/K052243
Methodology: https://510kreport.com/methodology