Digi-Pro TENS, Model WL-2204 and WL-2205
FDA 510(k) K020314 · Well-Life Healthcare, Inc.
510(k) numberK020314
Submission
- Device name
- Digi-Pro TENS, Model WL-2204 and WL-2205
- Applicant
- Well-Life Healthcare, Inc.
Taichung, R.O.C., TW - Received
- January 30, 2002
- Decision date
- April 30, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
| K240348 | Quantum Mitohormesis (QMT) (M2101)IPF · Abbreviated | Quantumtx Pte. , Ltd. | 12/19/2024SE |
| K240992 | eMVFit (MVF-10M)IPF · Traditional | Weero Co., Ltd. | 10/10/2024SE |
| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
More from Sunmed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P))KPI · Traditional | 02/12/2026SE |
| K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual…NUH · Traditional | 10/18/2024SE |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence…KPI · Traditional | 12/29/2022SE |
| K220524 | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)NUH · Traditional | 08/04/2022SE |
| K213091 | Well-Life TENS/EMS/Heating StimulatorNUH · Traditional | 02/19/2022SE |
| K200942 | Well-Life Garment Electrodes (GM Series)GXY · Traditional | 06/01/2021SE |
| K172809 | OTC Combo TENS/EMS SystemNUH · Special | 10/18/2017SE |
| K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and…GZJ · Traditional | 01/17/2017SE |
| K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605ANUH · Traditional | 12/05/2016SE |
| K141299 | OTC Combo Tens/Ems SystemNUH · Traditional | 11/14/2014SE |
Questions and answers
When was Digi-Pro TENS, Model WL-2204 and WL-2205 cleared by the FDA?
Digi-Pro TENS, Model WL-2204 and WL-2205 (K020314) received a 510(k) decision of Substantially Equivalent on April 30, 2002, 90 days after the submission was received.
What is the product code of K020314?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.