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NOVOPRESS

by Milka, LLC

510(k) K131416

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 NumberK131416 Date23 Jun 2014ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

NOVOPRESS is a sleeve, limb, compressible medical device designed for treating lymphedema and venous insufficiency. The device is manufactured by Milka, LLC and has been classified as a Class II medical device.

NOVOPRESS is supplied in various sizes as indicated by the multiple registration numbers. The device has received FDA 510(k) clearance with K131416, making it substantially equivalent to other devices in its product code category JOW. It is regulated under regulation number 870.5800.

Questions

AI-generated answers, 24 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 NOVOPRESS used for?

    NOVOPRESS is a sleeve, limb, compressible medical device designed specifically for treating lymphedema and venous insufficiency conditions. It provides compression therapy to help manage these circulatory disorders.

  • How is NOVOPRESS supplied and what sizes are available?

    NOVOPRESS is supplied in various sizes as indicated by multiple registration numbers. The manufacturer offers different sizes to accommodate different patient needs and treatment requirements for lymphedema and venous insufficiency.

  • What is the regulatory status of NOVOPRESS?

    NOVOPRESS has received FDA 510(k) clearance with K131416, making it substantially equivalent to other devices in its product code category JOW. It is regulated under regulation number 870.5800 as a Class II medical device.

  • Is NOVOPRESS a single-use or reusable device?

    The device data does not specify whether NOVOPRESS is designed for single-use or multiple uses. This information would be detailed in the product's instructions for use, which should be consulted for proper handling and disposal guidelines.