Well-Life Healthcare Limited
Jhonghe Taipei, TW
Well-Life Healthcare Limited appears in FDA device records in Jhonghe Taipei, TW. FDA records list 29 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 29 510(k) clearances for Well-Life Healthcare Limited between 2002 and 2026. The busiest year on record is 2002, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 3 |
| 2003 | 2 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2016 | 1 |
| 2017 | 2 |
| 2021 | 1 |
| 2022 | 3 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) | KPI | Substantially Equivalent | |
| K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator | NUH | Substantially Equivalent | |
| K222528 | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode | KPI | Substantially Equivalent | |
| K220524 | Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) | NUH | Substantially Equivalent | |
| K213091 | Well-Life TENS/EMS/Heating Stimulator | NUH | Substantially Equivalent | |
| K200942 | Well-Life Garment Electrodes (GM Series) | GXY | Substantially Equivalent | |
| K172809 | OTC Combo TENS/EMS System | NUH | Substantially Equivalent | |
| K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A | GZJ | Substantially Equivalent | |
| K161453 | WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A | NUH | Substantially Equivalent | |
| K141299 | OTC COMBO TENS/EMS SYSTEM | NUH | Substantially Equivalent | |
| K133723 | OTC PATCH | NUH | Substantially Equivalent | |
| K123075 | BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E | NGX | Substantially Equivalent | |
| K121353 | MINI PATCH | NUH | Substantially Equivalent | |
| K102786 | WELL-LIFE OTC EMS SYSTEM | NGX | Substantially Equivalent | |
| K100399 | 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A | GZJ | Substantially Equivalent | |
| K091757 | OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 | NUH | Substantially Equivalent | |
| K092763 | IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D | LIH | Substantially Equivalent | |
| K082065 | WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP | GXY | Substantially Equivalent | |
| K090023 | IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E | LIH | Substantially Equivalent | |
| K080304 | PRO TENS, MODEL WL-240 RX | GZJ | Substantially Equivalent | |
| K072168 | OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 | NGX | Substantially Equivalent | |
| K063660 | OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 | NUH | Substantially Equivalent | |
| K052785 | OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406 | NUH | Substantially Equivalent | |
| K040512 | LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 | GZJ | Substantially Equivalent | |
| K033857 | T-TECH DIGITAL, MODEL WL-22XXA SERIES | GZJ | Substantially Equivalent | |
| K030537 | DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B | GZJ | Substantially Equivalent | |
| K020020 | THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302) | GZJ | Substantially Equivalent | |
| K021359 | DIGI-PRO TENS MODEL WL-2203 AND WL-2205 | GZJ | Substantially Equivalent | |
| K020314 | DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 | IPF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006850006 | 3006850006 | Well-Life Healthcare Limited | 6F., No.168, Lide St.,, Jhonghe Taipei 235 TW | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IKDCable, Electrode
- ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
- GXYElectrode, Cutaneous
- LIHInterferential Current Therapy
- IRTPad, Heating, Powered
- HIRPerineometer
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- NYNStimulator, Electrical, Transcutaneous, For Arthritis
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain