# K121001: Copression Systems (Models CMP-001 and CMP-002)

- Pathway: 510(k) (Traditional)
- Applicant: Novitas Medical, LLC
- Decided: Apr 17, 2012 after 15 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 Compression System is intended to function as an intermittent, sequential pneumatic compression device and each model provides the following specific therapeutic functions: The CMP-OO1 (Compression Plus) is intended for: • Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venious Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema, chronic lymphedema. • Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains. • Optional localized thermal therapy (hot or cold) for post traumatic and post surgical, medical and/or surgical conditions • Aids the blood flow back to the heart • Treats and assists healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications The CMP-002 (DVrmax) is intended for: • Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema chronic lymphedema • Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains • Optional localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions • Decrease the risk of deep venious thrombosis (DVT) • Aids the blood flow back to the heart, • Treats and assists healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications The device is intended for home or hospital use and the target patient population is adults.

Source page: https://510kreport.com/device/K121001
Methodology: https://510kreport.com/methodology