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Copression Systems (Models CMP-001 and CMP-002)

by Novitas Medical, LLC

510(k) K121001

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121001 Date17 Apr 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JOW
Device Class
Class II
Regulation
21 CFR Part 870.5800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Copression Systems (Models CMP-001 and CMP-002) are compressible limb sleeves classified as a pneumatic compression device. These systems function as intermittent, sequential pneumatic compression devices that apply pressure to limbs to aid blood flow, reduce edema, and treat vascular or lymphatic insufficiency.

The device is intended for use in home or hospital settings by adults and is authorized under FDA 510(k) clearance K121001. The system is supplied as a Class II medical device under product code JOW. Model CMP-002 is specifically indicated to reduce the risk of deep vein thrombosis (DVT).

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Copression Systems?

    These systems are designed as intermittent, sequential pneumatic compression devices that apply pressure to limbs. They are used to aid blood flow, reduce edema, and treat vascular or lymphatic insufficiency.

  • Are there specific clinical indications for the different models?

    Both models are used for general compression therapy; however, Model CMP-002 is specifically indicated to help reduce the risk of deep vein thrombosis (DVT).

  • Where can the Copression Systems be used?

    The device is intended for use by adults in both home and hospital settings, providing flexibility for patients requiring ongoing compression therapy in different environments.

  • What is the regulatory status of this device?

    The Copression Systems are classified as Class II medical devices under product code JOW and are authorized for use under FDA 510(k) clearance K121001.