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Smartwave IF 2000

by Newwave Medical, LLC

510(k) K003631

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 NumberK003631 Date10 Aug 2001ClearedStatusActive

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  • Withdrawn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
LIH
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 IF 2000 is an interferential current therapy device, classified as a Class II medical device. It is designed to provide therapeutic electrical stimulation for neurological applications.

The device is manufactured by Newwave Medical, LLC and received FDA 510(k) clearance as substantially equivalent on August 10, 2001. It is regulated under product code LIH and regulation number 882.5890, with a neurology review panel. The device is supplied with various registration numbers and is intended for use in clinical settings.

Other devices from Newwave Medical, LLC

Questions

AI-generated answers, 1 Oct 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 IF 2000 device used for?

    The Smartwave IF 2000 is an interferential current therapy device designed to provide therapeutic electrical stimulation specifically for neurological applications in clinical settings.

  • How is the Smartwave IF 2000 supplied and what are its regulatory details?

    The device is supplied with various registration numbers and is regulated under product code LIH with regulation number 882.5890. It received FDA 510(k) clearance as substantially equivalent on August 10, 2001, and is classified as a Class II medical device.

  • Is the Smartwave IF 2000 a single-use or reusable device?

    The device data does not specify whether the Smartwave IF 2000 is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.

  • What sizes and models of the Smartwave IF 2000 are available?

    The device data does not provide information about different sizes or models of the Smartwave IF 2000. All available specifications would need to be obtained from the manufacturer or product documentation.