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Gemore OTC TENS

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K150681

by Gemore Technology Co., Ltd.

Identifiers

510(k) Number
K150681 FDA 510(k)
FDA Product Code
NUH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5890 FDA 510(k)
Regulation Number
882.5890 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Gemore OTC TENS is a transcutaneous electrical nerve stimulation (TENS) device classified under the product code NUH for neuromuscular electrical stimulation. It delivers low-voltage electrical pulses via electrodes to the skin for pain relief, targeting peripheral nerve pathways to modulate pain signals without invasive procedures.

This device is intended for over-the-counter use and is designed for home-based pain management. Supplied as a reusable, non-sterile unit, it features a dual-channel configuration with an LCD display and intuitive controls for mode and timer settings. Authorized under FDA 510(k) clearance (K150681) and MDR compliance, it adheres to regulatory standards for neuromuscular stimulation devices.

Frequently asked questions

Is the Gemore OTC TENS device meant for professional clinical use or can it be used at home by consumers?

The Gemore OTC TENS is explicitly designed for over-the-counter (OTC) use, meaning it is intended for home-based pain management by consumers. It does not require professional supervision or clinical administration, making it accessible for self-treatment of pain.

How many channels does the Gemore OTC TENS device have, and what does this mean for its functionality?

The Gemore OTC TENS features a dual-channel configuration, allowing it to simultaneously deliver electrical pulses to two separate areas of the body. This enables targeted pain relief across multiple regions, enhancing flexibility for users managing localized or widespread discomfort.

Can the Gemore OTC TENS device be reused, or is it intended for single-use only?

The Gemore OTC TENS is supplied as a reusable, non-sterile unit. Since it is not intended for sterile procedures, it is designed for repeated use by the same consumer for home-based pain management, provided it is maintained according to the manufacturer’s instructions.

What kind of controls does the Gemore OTC TENS device have, and how does this affect usability?

The device includes an LCD display paired with intuitive controls for adjusting modes and timer settings. This design ensures ease of use, allowing consumers to customize their pain relief experience without requiring technical expertise or assistance.

What regulatory pathways has the Gemore OTC TENS device followed, and what does this mean for its compliance?

The device has undergone FDA 510(k) clearance (K150681) and complies with the EU Medical Device Regulation (MDR). This means it meets U.S. and European regulatory standards for neuromuscular electrical stimulation devices, ensuring safety and performance as intended for over-the-counter pain management.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: OTC TENS for Pain | Products > OTC TENS/EMS series | Gemore Technology ..., TENS | Products > Digital TENS | Gemore Technology Co., Ltd., GEMORE OTC TENS (K150681) — FDA 510(k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Gemore Technology Co., Ltd.
FDA Applicant
Gemore Technology Co, Ltd.

Sources (2)

  • FDA 510(k) K150681 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 29, 2026