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Maxpower Relief

by Omron Healthcare, Inc. 2 variants

510(k) K141978

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 NumberK141978 Date3 Dec 2014ClearedStatusActive

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  • Withdrawn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
NUH
Device class
Class II
Regulation
21 CFR Part 882.5890
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Maxpower Relief is a transcutaneous electrical nerve stimulator (TENS unit), classified under product code NUH. It delivers low-voltage electrical currents to the skin’s surface to modulate pain signals, providing drug-free relief for muscle and joint discomfort.

This device is intended for over-the-counter use and is supplied as a reusable, non-sterile medical instrument. It operates without MRI restrictions and is authorised under FDA 510(k) clearance (K141978 and K182120). Storage and handling follow standard electrical medical device guidelines.

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See all devices from Omron Healthcare, Inc. →

Questions

AI-generated answers, 18 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 types of pain can the Maxpower Relief TENS unit help manage, and is it suitable for chronic or acute discomfort?

    The Maxpower Relief is designed to provide drug-free relief for muscle and joint discomfort, making it suitable for managing mild to moderate pain associated with these areas. While it can be used for acute discomfort, its primary indication is for chronic or recurring pain relief, as it modulates pain signals through low-voltage electrical currents delivered to the skin’s surface. It is not intended for severe pain or conditions requiring medical intervention beyond pain management.

  • Is the Maxpower Relief TENS unit reusable, and if so, how should it be cleaned and maintained?

    Yes, the Maxpower Relief is supplied as a reusable, non-sterile device. Since it is not sterile, it should be cleaned according to standard electrical medical device guidelines after each use to ensure hygiene and longevity. Avoid submerging it in water, and use a mild, non-abrasive cleaner on the external surfaces. Always follow the manufacturer’s instructions for proper storage and maintenance to maintain its functionality and safety.

  • Can I use the Maxpower Relief TENS unit if I have an MRI scan scheduled, or does it interfere with MRI procedures?

    No, the Maxpower Relief does not have MRI restrictions, meaning it is safe to use if you have an MRI scan scheduled. However, always consult your healthcare provider for personalized advice, as individual medical conditions may still require caution. The device is designed to operate without interfering with MRI procedures, but it’s important to follow standard guidelines for electrical medical devices in clinical settings.

  • What storage conditions should I follow for the Maxpower Relief TENS unit to ensure it remains functional?

    The Maxpower Relief should be stored following standard electrical medical device guidelines. Keep it in a dry, clean environment away from direct sunlight, extreme temperatures, and moisture. Avoid storing it in areas with high humidity or where it could be exposed to dust or contaminants. Proper storage helps maintain the device’s performance and ensures its safety for repeated use.

  • How do I know which model or size of the Maxpower Relief is right for me, and does it come with different electrode options?

    The Maxpower Relief is a single device model designed for general over-the-counter use, targeting muscle and joint discomfort. While the device itself does not vary in size or model, it typically comes with reusable adhesive electrodes that may vary in size depending on the manufacturer’s design. Check the packaging or user manual for electrode specifications, as larger electrodes may be better suited for broader areas of discomfort, while smaller ones may be more precise for targeted relief. Always refer to the included instructions for proper application.