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Fd Tens 2070

by Fuji Dynamics, Ltd. 510(k)

Active United States

510(k) K111654

Overview

The FD TENS 2070 is a transcutaneous nerve stimulator, classified under product code GZJ. It is designed to provide electrical stimulation for pain relief by delivering controlled electrical impulses to nerve pathways through the skin, helping manage chronic or acute pain conditions.

This device is intended for single-use or reusable applications, depending on manufacturer guidelines, and is regulated under FDA 510(k) clearance (K111654) with a decision date of March 1, 2012. It falls under the Neurology advisory committee review and is classified as Class II with special controls. No specific sterility or MRI safety information is provided in the available data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111654 Date1 Mar 2012ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GZJ
FDA applicant
Fuji Dynamics , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the FD TENS 2070 used for?

    The FD TENS 2070 is a transcutaneous nerve stimulator designed to provide pain relief by delivering controlled electrical impulses through the skin. It targets nerve pathways to help manage chronic or acute pain conditions, offering a non-invasive alternative for pain management.

  • Is the FD TENS 2070 intended for single-use or reusable applications?

    The FD TENS 2070 can be used either as a single-use device or reused, depending on the manufacturer’s guidelines. The manufacturer has not specified sterility requirements or reuse protocols in the available data, so adherence to proper cleaning and maintenance procedures is essential if reused.

  • What regulatory clearance does the FD TENS 2070 hold?

    The FD TENS 2070 holds FDA 510(k) clearance under the classification of product code GZJ, with a decision date of March 1, 2012. It was reviewed by the Neurology Advisory Committee and is classified as a Class II device with special controls.

  • Does the FD TENS 2070 have any specific safety information regarding MRI compatibility?

    The available data does not provide explicit information about the MRI safety of the FD TENS 2070. If MRI compatibility is a concern, users should consult the manufacturer’s instructions or contact Fuji Dynamics, Ltd. for guidance.

  • How should the FD TENS 2070 be stored?

    While specific storage instructions are not detailed in the provided data, most transcutaneous nerve stimulators should be stored in a clean, dry environment, protected from extreme temperatures and direct sunlight. Always follow the manufacturer’s guidelines for optimal performance and longevity.