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Duomed, Series 500, (Models Id 500, Fl 500)

by Duomed, Inc.

510(k) K030140

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 NumberK030140 Date18 Mar 2003ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 21 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 Duomed Series 500 is a transcutaneous electrical nerve stimulator designed for pain relief. It functions as a non-invasive nerve stimulation therapy device indicated for the symptomatic relief and management of long-term pain.

This device is identified by models ID 500 and FL 500 and is regulated under 21 CFR 882.5890. It has received FDA 510(k) clearance as a Class II medical device.

Questions

AI-generated answers, 21 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 function of the Duomed Series 500?

    The Duomed Series 500 is a transcutaneous electrical nerve stimulator designed to provide non-invasive therapy for the symptomatic relief and management of long-term pain.

  • Which specific models are included in the Series 500?

    The Series 500 product line consists of two distinct models, identified as ID 500 and FL 500, both of which are regulated under 21 CFR 882.5890.

  • What is the regulatory status of this device?

    The Duomed Series 500 is a Class II medical device that has received FDA 510(k) clearance, as indicated by the submission number K030140.