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OTC TENS for Arm and Leg Pain Relief, Model WL-2407

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091757

by Well-Life Healthcare Limited

Identifiers

510(k) Number
K091757 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)

This device is a Transcutaneous Electrical Nerve Stimulation (TENS) unit designed for over-the-counter use to provide pain relief for arm and leg discomfort. It delivers low-voltage electrical pulses through electrodes to the skin, modulating pain signals along nerve pathways to alleviate symptoms without pharmacological intervention.

The TENS unit, Model WL-2407, is supplied as a non-reusable, non-sterile device intended for home or clinical use. It operates under FDA clearance (510K, K091757) and falls under the Neurology specialty classification, adhering to traditional review standards. No MRI safety or specific storage conditions are noted in the regulatory data.

Frequently asked questions

What types of arm and leg discomfort can this TENS unit help relieve, and how does it work to provide pain relief?

This TENS unit (Model WL-2407) is designed for over-the-counter use to relieve general arm and leg discomfort by delivering low-voltage electrical pulses through electrodes placed on the skin. It works by modulating pain signals along nerve pathways, helping to alleviate symptoms without the need for medication. It’s intended for mild to moderate discomfort, such as muscle aches, joint pain, or nerve-related discomfort in these areas.

Is this device meant for single-use or repeated use, and how should it be stored?

The TENS unit (Model WL-2407) is a non-reusable device, meaning it is intended for one-time use per session. Since it is non-sterile, there are no specific storage conditions like temperature or humidity requirements mentioned in the regulatory data. However, it should be stored in a clean, dry place away from direct sunlight or moisture to maintain its functionality.

What regulatory pathway was followed for this device, and what does that mean for its safety and approval?

This device was cleared through the FDA’s 510(k) pathway (K091757) under traditional review standards, with a decision of ‘Substantially Equivalent’ to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for over-the-counter pain relief in arm and leg discomfort.

Can this device be used in a clinical setting, or is it only for home use?

While the device is labeled for both home and clinical use, its non-sterile and non-reusable nature makes it more practical for home use or non-invasive clinical applications where sterility is not required. Clinicians should ensure proper training and adherence to manufacturer guidelines when using it in a clinical environment.

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 Arm and Leg Pain Relief, Model Wl-2407 (K091757) — Fda 510 ..., Otc Tens for Arm and Leg Pain Relief, Model Wl-2407, Otc Tens for Arm and Leg Pain Relief, Model Wl-2407, PDF OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 510 (k) K091757 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Well-Life Healthcare Limited

Sources (1)

  • FDA 510(k) K091757 24 fields · synced Oct 6, 2026