Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS with Menstrual Relief Stimulator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233054 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
- Models / Variants
- TENS/EMS WITH Menstrual Relief Stimulator FDA 510(k)Well-Life Pain Relief Stimulator FDA 510(k)Menstrual Plus Stimulator 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) and Electromyostimulation (EMS) unit designed for the symptomatic relief of menstrual pain. It falls under the classification of a neuromodulation device, delivering low-voltage electrical impulses to alleviate discomfort associated with dysmenorrhea through targeted nerve stimulation.
The Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator is supplied as a reusable device, intended for home or clinical use. It operates under FDA 510(k) clearance (K233054) and is classified under product code NUH. No specific sterility or MRI safety information is provided in the regulatory data, and the device is available in models WL-2315C(M) and WL-2315E(M).
Frequently asked questions
What specific types of menstrual discomfort does this device target, and how does it work to provide relief?
This device is designed to provide symptomatic relief for menstrual pain, specifically targeting dysmenorrhea (painful menstruation). It achieves this through Transcutaneous Electrical Nerve Stimulation (TENS) and Electromyostimulation (EMS), delivering low-voltage electrical impulses to stimulate nerves and muscles. The targeted nerve stimulation helps block pain signals and relaxes uterine muscles, reducing discomfort during menstruation.
Is this device meant for single-use or repeated use, and how should it be maintained?
The Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator is a reusable device, intended for both home and clinical use. Since it is not sterile and no specific cleaning instructions are provided in the regulatory data, users should follow manufacturer guidelines for proper maintenance to ensure hygiene and longevity. This typically includes wiping down the device with a mild disinfectant between uses and storing it in a clean, dry place.
What models are available, and are there any differences between them?
The device is available in two models: WL-2315C(M) and WL-2315E(M). While the exact differences between these models are not detailed in the regulatory data, the inclusion of (M) may indicate minor variations such as additional features, electrode configurations, or user interface adjustments. For precise distinctions, refer to the manufacturer’s user manual or contact Well-Life Healthcare Limited.
How should this device be stored, and are there any special considerations for its environment?
The device should be stored in a clean, dry environment away from direct sunlight, moisture, or extreme temperatures. Since it is reusable and not sterile, it’s important to keep it protected from dust and contaminants to maintain its functionality and hygiene. The manufacturer’s instructions should be followed for optimal storage conditions, though no specific storage requirements are mentioned in the regulatory data.
What regulatory pathway was followed for this device’s approval, and which committee was involved?
This device was cleared through the FDA’s 510(k) pathway, specifically under the Traditional clearance type with the Neurology advisory committee (NE) review. The submission was deemed Substantially Equivalent (SESE) to a predicate device, and the clearance number is K233054. The product code assigned is NUH, which categorizes it under neuromodulation devices.
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: Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS ..., Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS ..., Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233054 | Class II | Active |
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Manufacturer
- Manufacturer
- Well-Life Healthcare Limited
Sources (1)
- FDA 510(k) K233054 24 fields · synced Oct 6, 2026