If True Sine Interferential Stimulator WL-2206D
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092763 FDA 510(k)
- FDA Product Code
- LIH 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 If True Sine Interferential Stimulator WL-2206D is an interferential current therapy device designed to deliver true-sine electrical pulses for neuromuscular stimulation. It operates by generating alternating current through electrodes applied to the skin, facilitating pain management and muscle stimulation via interferential effects between two medium-frequency currents.
This device is intended for clinical use in neurology settings and is supplied as a reusable medical instrument. It features push-button controls for intensity adjustment, replacing the traditional turning knob of its predicate device. The WL-2206D holds FDA 510(k) clearance under Special Panel NE (Neurology) with classification as a Class II device under regulation number 882.5890, and is intended for TENS-indicated applications.
Frequently asked questions
What is the If True Sine Interferential Stimulator WL-2206D used for?
The If True Sine Interferential Stimulator WL-2206D is designed for neuromuscular stimulation and pain management. It achieves this by generating alternating current through electrodes applied to the skin, creating an interferential effect between two medium-frequency currents. This technology is particularly useful in clinical neurology settings for TENS (Transcutaneous Electrical Nerve Stimulation)-indicated applications, helping to alleviate pain and stimulate muscles.
How is the If True Sine Interferential Stimulator WL-2206D supplied and intended for use?
The WL-2206D is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical environments after proper cleaning and maintenance. Its design includes push-button controls for adjusting intensity, which improves usability compared to traditional turning knobs found in older models. This makes it suitable for ongoing patient care in neurology departments.
Is the If True Sine Interferential Stimulator WL-2206D sterile?
The device itself is not sterile out of the box as it is a reusable medical instrument. Sterility is not required for reusable devices like this one, but it must be thoroughly cleaned and disinfected between uses to maintain hygiene standards. Proper sterilization protocols should follow manufacturer guidelines to ensure safe and effective clinical use.
What distinguishes the WL-2206D from other interferential stimulators?
The WL-2206D is distinguished by its true-sine wave technology, which provides more accurate and comfortable electrical pulses for neuromuscular stimulation. Additionally, it features intuitive push-button controls for intensity adjustment, replacing the older knob-based design. This enhances precision and ease of use for clinicians managing pain and muscle stimulation in neurology patients.
What regulatory approval does the If True Sine Interferential Stimulator WL-2206D hold?
The WL-2206D holds FDA 510(k) clearance under Special Panel NE (Neurology) and is classified as a Class II device under regulation number 882.5890. This clearance indicates that the device has been deemed substantially equivalent to a predicate device already on the market, ensuring it meets regulatory standards for safety and effectiveness in its intended clinical applications.
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: If True Sine Interferential Stimulator, Wl-2206d, IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D by WELL-LIFE ..., If Series True Sine Interferential Stimulator/Model: Wl-2206, Well If ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092763 | Class II | Active |
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Manufacturer
- Manufacturer
- Well-Life Healthcare Limited
Sources (1)
- FDA 510(k) K092763 24 fields · synced Oct 5, 2026