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Auto-Tens Model V

by Cbc Corp.

510(k) K832337

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 NumberK832337 Date31 Aug 1983ClearedStatusActive

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  • Withdrawn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, 6 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 Auto-Tens Model V is a transcutaneous electrical nerve stimulation (TENS) device, as indicated by its device name and product code GZJ. It is a medical device designed for electrical stimulation therapy.

It was cleared by the FDA through the 510(k) process under submission K832337, with a decision date of August 31, 1983. The device is manufactured by Cbc Corp. and is substantially equivalent to a legally marketed predicate device.

Other devices from Cbc Corp.

Questions

AI-generated answers, 6 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 Auto-Tens Model V used for?

    The Auto-Tens Model V is a transcutaneous electrical nerve stimulation (TENS) device designed for electrical stimulation therapy, as indicated by its device name and product code GZJ, delivering non-invasive nerve stimulation through the skin.

  • How was the Auto-Tens Model V cleared for market?

    The Auto-Tens Model V received FDA clearance through the traditional 510(k) process under submission K832337, with a decision date of August 31, 1983, based on a finding of substantial equivalence to a legally marketed predicate device.

  • Who manufactures the Auto-Tens Model V and where is it located?

    The Auto-Tens Model V is manufactured by Cbc Corp., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, as specified in the device’s authorization records.