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Gemore TENS System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K120569

by Gemore Technology Co., Ltd.

Identifiers

510(k) Number
K120569 FDA 510(k)
FDA Product Code
GZJ 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 TENS System is a transcutaneous electrical nerve stimulation (TENS) device, classified under neuromodulation technology. It delivers low-voltage electrical pulses to the skin to alleviate pain by interfering with pain signal transmission along nerve pathways, typically used for chronic or acute pain management.

This system is supplied as a reusable medical device, intended for use in clinical and home settings. It operates under FDA 510(k) clearance (K120569) and EU MDR compliance, with no third-party certification required. The device is non-MRI-safe and must be stored in a clean, dry environment as per manufacturer guidelines.

Frequently asked questions

Is the Gemore TENS System designed for single-use or can it be reused in clinical settings?

The Gemore TENS System is explicitly labeled as a reusable medical device, meaning it is intended for repeated use in both clinical and home settings. Since it is not classified as single-use, proper cleaning and maintenance per manufacturer guidelines are required to ensure safe and effective operation over multiple uses.

How should the Gemore TENS System be stored to maintain its functionality and safety?

The device must be stored in a clean, dry environment to prevent damage or contamination. The manufacturer explicitly recommends this to preserve its performance and ensure safety, as it is not waterproof or designed for wet conditions.

Can the Gemore TENS System be used inside an MRI scanner, or does it pose any risks?

The Gemore TENS System is not MRI-safe, meaning it should never be used in or near an MRI environment. Electrical stimulation devices like this can interfere with MRI operations or pose safety risks to patients during imaging, so strict avoidance is required.

What regulatory pathways does the Gemore TENS System follow in the U.S. and Europe?

In the U.S., the device is cleared via the FDA 510(k) pathway under clearance number K120569, classified as substantially equivalent to a predicate device. In Europe, it complies with EU MDR (Medical Device Regulation) but does not require third-party certification. Both pathways confirm its safety and performance for neuromodulation-based 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.

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) K120569 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026