# K973592: Walkcare P200 System

- Pathway: 510(k) (Traditional)
- Applicant: A.Stein - Regulatory Affairs Consulting
- Decided: May 20, 1999 after 605 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Walkcare P200 system is indicated for improved blood circulation, prevention of deep vein thrombosis and reduces pain, chronic and acute edema, leg ulcers, compartmental pressure, venous stasis and complications of poor circulation, in the lower extremeties.

Source page: https://510kreport.com/device/K973592
Methodology: https://510kreport.com/methodology