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StimPlus Patch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200561

by JKH Health Co., Ltd.

Identifiers

510(k) Number
K200561 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 StimPlus Patch is a transcutaneous electrical nerve stimulator (TENS), classified under 21 CFR 882.5890. It delivers low-voltage electrical impulses through adhesive patches to the skin, targeting nerve pathways to alleviate pain without invasive procedures. Designed for over-the-counter use, it is intended for non-prescription application in neurological pain management. The device operates on a portable, battery-powered system for user-friendly administration.

The StimPlus Patch is supplied as a single-use, non-sterile medical device intended for home or clinical settings where pain relief is required. It is regulated under FDA 510(k) clearance (K200561) as substantially equivalent to existing devices, with no MRI safety restrictions specified. Storage instructions are not detailed in the data, but typical TENS devices require protection from moisture and extreme temperatures. The device is classified as Class II under FDA regulations.

Frequently asked questions

What is the StimPlus Patch used for?

The StimPlus Patch is a transcutaneous electrical nerve stimulator (TENS) designed to alleviate neurological pain without invasive procedures. It works by delivering low-voltage electrical impulses through adhesive patches to the skin, targeting nerve pathways to provide relief. It is intended for over-the-counter use in both home and clinical settings where pain management is required.

Is the StimPlus Patch single-use or reusable?

The StimPlus Patch is classified as a single-use device. This design ensures hygiene and safety, particularly in clinical or home settings where multiple users may not be present. Single-use devices are typically discarded after one application to prevent cross-contamination and maintain sterility standards.

What are the storage requirements for the StimPlus Patch?

While specific storage instructions are not detailed in the provided data, typical TENS devices like the StimPlus Patch should be stored in a dry environment, protected from moisture and extreme temperatures. Avoid exposure to direct sunlight or humidity, as these conditions can degrade the adhesive patches or battery performance. Always follow general medical device storage guidelines unless manufacturer-specific instructions are provided.

Can the StimPlus Patch be used during an MRI scan?

The provided data does not specify any MRI safety restrictions for the StimPlus Patch. However, as a general precaution, electrical medical devices should not be used near MRI machines unless explicitly approved for MRI compatibility. Always consult the device’s instructions or a healthcare professional before use in an MRI environment.

How is the StimPlus Patch powered, and is it portable?

The StimPlus Patch operates on a battery-powered system, making it highly portable and user-friendly. The compact design allows for easy administration in various settings, including home use or clinical environments. The battery ensures convenience without the need for external power sources, aligning with the device’s over-the-counter and non-invasive application.

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: StimPlus Patch, StimPlus Patch, StimPlus Patch (K200561) — FDA 510(k ..., StimPlus Patch, StimPlus Patch, StimPlus Patch… - FDA.report, K200561 - StimPlus Patch | FDA 510 (k) | Jkh Health Co., Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
JKH Health Co., Ltd.

Sources (1)

  • FDA 510(k) K200561 24 fields · synced Oct 1, 2026