Company ยท TW
Well-Life Healthcare Limited
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2026. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 11 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 8 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 3 |
| GXY | Electrode, Cutaneous | 2 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 |
| LIH | Interferential Current Therapy | 2 |
| IPF | Stimulator, Muscle, Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2026 | K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) Well-Life Healthcare , Ltd., TW | KPI |
| Oct 18, 2024 | K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Well-Life Healthcare Limited, TW | NUH |
| Dec 29, 2022 | K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Healthcare Limited, TW | KPI |
| Aug 4, 2022 | K220524 | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) Well-Life Healthcare Limited, TW | NUH |
| Feb 19, 2022 | K213091 | Well-Life TENS/EMS/Heating Stimulator Well-Life Healthcare Limited, TW | NUH |
| Jun 1, 2021 | K200942 | Well-Life Garment Electrodes (GM Series) Well-Life Healthcare Limited, TW | GXY |
| Oct 18, 2017 | K172809 | OTC Combo TENS/EMS System Well-Life Healthcare Limited, TW | NUH |
| Jan 17, 2017 | K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A Well-Life Healthcare Limited, TW | GZJ |
| Dec 5, 2016 | K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A Well-Life Healthcare Limited, TW | NUH |
| Nov 14, 2014 | K141299 | OTC COMBO TENS/EMS SYSTEM Well-Life Healthcare Limited, TW | NUH |
| Jan 28, 2014 | K133723 | OTC PATCH Well-Life Healthcare Limited, TW | NUH |
| Jul 11, 2013 | K123075 | BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E Well-Life Healthcare Limited, TW | NGX |
| Sep 7, 2012 | K121353 | MINI PATCH Well-Life Healthcare Limited, TW | NUH |
| Jul 1, 2011 | K102786 | WELL-LIFE OTC EMS SYSTEM Well-Life Healthcare Limited, TW | NGX |
| Jun 25, 2010 | K100399 | 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A Well-Life Healthcare Limited, TW | GZJ |
| Feb 5, 2010 | K091757 | OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 Well-Life Healthcare Limited, TW | NUH |
| Oct 8, 2009 | K092763 | IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D Well-Life Healthcare Limited, TW | LIH |
| Apr 10, 2009 | K082065 | WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP Well-Life Healthcare Limited | GXY |
| Jan 30, 2009 | K090023 | IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E Well-Life Healthcare Limited, TW | LIH |
| Jun 20, 2008 | K080304 | PRO TENS, MODEL WL-240 RX Well-Life Healthcare Limited, TW | GZJ |
| Dec 19, 2007 | K072168 | OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 Well-Life Healthcare Limited, TW | NGX |
| Feb 7, 2007 | K063660 | OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 Well-Life Healthcare Limited, HK | NUH |
| Mar 17, 2006 | K052785 | OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406 Well-Life Healthcare Limited, HK | NUH |
| May 27, 2004 | K040512 | LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 Well-Life Healthcare, Inc. | GZJ |
| Dec 19, 2003 | K033857 | T-TECH DIGITAL, MODEL WL-22XXA SERIES Well-Life Healthcare, Inc., TW | GZJ |
| Mar 20, 2003 | K030537 | DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B Well-Life Healthcare, Inc., TW | GZJ |
| Dec 30, 2002 | K020020 | THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302) Well-Life Healthcare, Inc., TW | GZJ |
| Apr 30, 2002 | K021359 | DIGI-PRO TENS MODEL WL-2203 AND WL-2205 Well-Life Healthcare, Inc., TW | GZJ |
| Apr 30, 2002 | K020314 | DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 Well-Life Healthcare, Inc., TW | IPF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||