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Rebox II (TENS)

by Rebox (Uk), Ltd.

510(k) K895183

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 NumberK895183 Date19 Jan 1990ClearedStatusActive

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  • Withdrawn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
FDA applicant
Rebox (Uk) , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Rebox II is a Transcutaneous Electrical Nerve Stimulation (TENS) device, classified under product code GZJ. It is designed to deliver low-intensity direct current pulses for pain management and neuromodulation, targeting nerve pathways to alleviate discomfort through electrical stimulation.

This device is supplied as a reusable medical instrument and is intended for clinical use in settings such as physiotherapy or pain management clinics. It operates with adjustable amplitudes up to 200 microamperes and frequencies between 2 to 4 kHz, as substantiated by its FDA 510(k) clearance under the Traditional pathway. No specific sterility or single-use requirements are noted, and its MRI safety profile is not documented in the available data.

Questions

AI-generated answers, 1 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 Rebox II TENS device used for?

    The Rebox II TENS device is designed to manage pain and promote neuromodulation by delivering low-intensity direct current pulses through transcutaneous electrical nerve stimulation. It targets nerve pathways to help alleviate discomfort, making it suitable for clinical use in environments such as physiotherapy or pain management clinics.

  • Is the Rebox II TENS device single-use or reusable?

    The Rebox II TENS device is supplied as a reusable medical instrument. This design allows for repeated use in clinical settings, provided proper maintenance and cleaning protocols are followed to ensure safety and efficacy.

  • What are the key specifications for the Rebox II TENS device?

    The Rebox II TENS device operates with adjustable amplitudes up to 200 microamperes and frequencies ranging between 2 to 4 kHz. These specifications are supported by its FDA 510(k) clearance under the Traditional pathway, ensuring its safety and performance for clinical pain management applications.

  • Does the Rebox II TENS device require any specific sterility measures?

    The available data does not specify any particular sterility requirements for the Rebox II TENS device. However, as it is a reusable medical instrument, standard clinical cleaning and disinfection protocols should be followed to maintain hygiene and prevent cross-contamination in clinical settings.

  • What regulatory pathway was used for the FDA clearance of the Rebox II TENS device?

    The Rebox II TENS device received its FDA clearance through the Traditional 510(k) pathway, which is used for devices that are substantially equivalent to legally marketed devices. This pathway was applied under the product code GZJ, and the device was reviewed by the Neurology Advisory Committee.