T-Tech Digital Model WL-22XXA Series
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K033857 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 T-Tech Digital Model WL-22XXA Series is a transcutaneous electrical nerve stimulation (TENS) and powered muscle stimulation (EMS) device. It functions by applying an adjustable electrical current to electrodes that are attached to the patient's skin to provide pain relief and muscle stimulation.
This device is authorized under FDA 510(k) clearance. It includes multiple models such as WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A, which feature adjustable output and waveforms to suit the patient's needs.
Frequently asked questions
What is the primary function of the T-Tech Digital WL-22XXA Series?
This device functions as both a transcutaneous electrical nerve stimulation (TENS) unit and a powered muscle stimulation (EMS) device. It works by applying an adjustable electrical current to electrodes placed on the patient's skin to facilitate pain relief and muscle stimulation.
Which specific models are included in the WL-22XXA series?
The series includes several distinct models to suit different patient needs, specifically the WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A. These models feature adjustable output and waveforms to allow for customized therapy.
What is the regulatory status of this device?
The T-Tech Digital Model WL-22XXA Series is authorized under FDA 510(k) clearance. It was reviewed under the neurology advisory committee and determined to be substantially equivalent to existing 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: T-TECH DIGITAL, MODEL WL-22XXA SERIES - Innolitics, T-tech Digital, Model Wl-22xxa Series 510 (k) FDA Premarket ..., fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033857 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Well-Life Healthcare, Inc.
Sources (1)
- FDA 510(k) K033857 24 fields · synced Oct 6, 2026