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Relief Band (T.E.N.S. Device)

by Maven Labs, Inc.

510(k) K901704

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 NumberK901704 Date19 Nov 1991ClearedStatusActive

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  • Withdrawn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.

The Relief Band is a Transcutaneous Electrical Nerve Stimulation (T.E.N.S.) device, classified under the product code GZJ. T.E.N.S. devices are designed to deliver low-level electrical currents to the body’s peripheral nerves, intended to modulate pain perception through non-invasive stimulation.

This device is supplied as a reusable medical instrument and is intended for use in clinical or home settings under professional guidance. It operates on standard electrical power and requires no sterilisation, as it is not intended for invasive procedures. The device was cleared by the FDA via a 510(k) submission (K901704) under the Neurology advisory committee, with a decision date of November 19, 1991.

Other devices from Maven Labs, Inc.

Questions

AI-generated answers, 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.

  • What is the Relief Band (T.E.N.S. Device) used for in clinical or home settings?

    The Relief Band is a Transcutaneous Electrical Nerve Stimulation (T.E.N.S.) device designed to deliver low-level electrical currents to peripheral nerves. It is intended to help modulate pain perception through non-invasive stimulation, providing relief for conditions where pain management is a priority. It operates under professional guidance in either clinical or home settings.

  • Is the Relief Band reusable or single-use, and does it require sterilization?

    The Relief Band is supplied as a reusable medical instrument, meaning it is intended for repeated use after proper cleaning. Since it is not designed for invasive procedures, sterilization is not required. However, it should be cleaned and maintained according to manufacturer guidelines to ensure safe and effective operation.

  • How is the Relief Band powered, and what type of electrical outlet does it require?

    The Relief Band operates on standard electrical power, meaning it connects to a typical household or clinical electrical outlet. No specialized power source or adapter is required, making it convenient for use in both home and clinical environments.

  • What regulatory pathway was followed for FDA clearance of the Relief Band?

    The Relief Band was cleared by the FDA through a 510(k) submission (K901704) under the Neurology advisory committee, with a decision date of November 19, 1991. The clearance was granted as Substantially Equivalent (SESE) to a predicate device, following a traditional review process.