# K203847: Reprocessed Tri Pulse Compression Garment

- Pathway: 510(k) (Traditional)
- Applicant: Renu Medical, Inc.
- Decided: May 7, 2021 after 127 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: 2 generations back to K012417 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031559: Renu Medical Reporcessed Compressible Limb Sleeves, Renu Medical, Inc. (2003) Summary page 5.

## Indications for use
The RENU Medical Reprocessed Tri Pulse Compression Garment are to be used as a non-invasive therapeutic method to help prevent Deep Vein Tlu·ombosis (DVT) and resulting pulmonary embolism.

Source page: https://510kreport.com/device/K203847
Methodology: https://510kreport.com/methodology