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TENSMAX

by Anritsu America Co.

510(k) K811499

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 NumberK811499 Date20 Aug 1981ClearedStatusActive

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  • Withdrawn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, 22 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 nerve stimulator for pain relief, classified under product code GZJ and regulation 882.5890. It is a medical device intended for the stimulation of nerves through the skin to alleviate pain.

It received FDA 510(k) clearance (K811499) on August 20, 1981, as substantially equivalent to a predicate device. The device is classified as Class II, with a traditional clearance type, and was reviewed by the Neurology advisory committee. It is manufactured by Anritsu America Co. and is authorized for use in the United States.

Other devices from Anritsu America Co.

  • Health Point

    Unclassified

Questions

AI-generated answers, 22 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 TENSMAX device used for?

    The TENSMAX device is intended for the stimulation of nerves through the skin to alleviate pain, as stated in its description. It functions as a transcutaneous nerve stimulator designed specifically for pain relief applications.

  • How was the TENSMAX device authorized for use in the United States?

    The TENSMAX device received FDA 510(k) clearance (K811499) on August 20, 1981, as substantially equivalent to a predicate device. This traditional clearance was reviewed by the Neurology advisory committee and authorized its use in the U.S.

  • Who manufactures the TENSMAX device and where is it located?

    The TENSMAX device is manufactured by Anritsu America Co., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, as indicated in the device data.