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Classic TENS

by Care Rehab, Inc.

510(k) K020437

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 NumberK020437 Date15 Mar 2002ClearedStatusActive

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  • Withdrawn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, 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.

This device is a transcutaneous electrical nerve stimulation (TENS) unit. It is designed to deliver electrical currents through the skin to stimulate nerves for therapeutic purposes.

It is supplied as a reusable device and has received FDA 510(k) clearance under K020437. The device is manufactured by Care Rehab, Inc. and is intended for use in clinical or home settings as indicated by its authorization and specifications.

Other devices from Care Rehab, Inc.

  • Care Tens

    Class II

  • Classic Nms

    Class II

  • Care Ifc Plus

    Class II