Ds-200 and Ds-400 T.E.N.S.

by Delta Marketing, Inc.

510(k) K881832

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

510(k) K881832↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK881832	Date1 Jul 1988Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K881832
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, 19 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 DS-200 and DS-400 are Transcutaneous Electrical Nerve Stimulation (TENS) units, designed to deliver low-voltage electrical currents through electrodes placed on the skin. These devices are intended for pain management by modulating nerve signals to reduce discomfort in targeted areas.

These units are supplied as reusable medical devices and are cleared for use in clinical and home settings. The DS-200 and DS-400 operate with adjustable output settings and are regulated under FDA 510(k) clearance (K881832) with a product code of GZJ. No specific sterility or MRI safety information is provided in the data.