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Smartwave MS 2000

by Newwave Medical, LLC

510(k) K041063

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 NumberK041063 Date1 Dec 2004ClearedStatusActive

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  • Withdrawn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
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Smartwave MS 2000 is a physical medicine device. It is designed for therapeutic applications in physical medicine settings.

The device is supplied by Newwave Medical, LLC and has received FDA 510(k) clearance with the product code IPF. It is intended for use in physical medicine and rehabilitation settings.

Other devices from Newwave Medical, LLC

Questions

AI-generated answers, 23 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 Smartwave MS 2000 device used for?

    The Smartwave MS 2000 is a physical medicine device designed for therapeutic applications in physical medicine and rehabilitation settings. It helps clinicians provide treatment for patients requiring physical medicine interventions.

  • How is the Smartwave MS 2000 supplied?

    The Smartwave MS 2000 is supplied by Newwave Medical, LLC. The device comes with all necessary components for therapeutic use in physical medicine settings, though specific packaging details aren't provided in the available information.

  • What is the regulatory status of the Smartwave MS 2000?

    The Smartwave MS 2000 has received FDA 510(k) clearance with the product code IPF. This means it has been determined to be substantially equivalent to existing devices for its intended use in physical medicine and rehabilitation settings.

  • Is the Smartwave MS 2000 reusable or single-use?

    The available information does not specify whether the Smartwave MS 2000 is designed for single-use or multiple uses. Clinicians should consult the manufacturer's instructions for use to determine the appropriate handling and disposal protocols for this device.