# Well-Life Healthcare Limited

- Location (FDA's records): Yunghe City, Taipei County, TW
- FDA decisions: 29 (2002–2026): 29 510(k) clearances
- Names in FDA's records: Well-Life Healthcare Limited (22); Well-Life Healthcare, Inc. (6); Well-Life Healthcare , Ltd. (1)
- Product codes: NUH (11), GZJ (8), NGX (3), LIH (2), KPI (2), GXY (2), IPF (1)
- 510(k) review time since 2016: median 162 days, against 145 for FDA's reviews in the same codes and years (2 of 9 faster)
- Predicates its devices cite: 33 (18 its own); citations of its devices by later devices: 36 (18 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Medical Research, Ltd.: 2 (https://510kreport.com/company/bio-medical-research)
- Lifecare, Ltd.: 1 (https://510kreport.com/company/lifecare)
- Theratech, Inc.: 1 (https://510kreport.com/company/theratech)
- Everyway Medical Instruments Co.,Ltd: 1 (https://510kreport.com/company/everyway-medical-instruments)
- Tenscare, Ltd.: 1 (https://510kreport.com/company/tenscare)
- Neurotron Medical: 1 (https://510kreport.com/company/neurotron-medical)
- Shenzhen Konmed Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-konmed-technology)
- Gemore Technology Co, Ltd.: 1 (https://510kreport.com/company/gemore-technology)

## Firms that cite its devices most
- Gemore Technology Co, Ltd.: 5 (https://510kreport.com/company/gemore-technology)
- Everyway Medical Instruments Co.,Ltd: 3 (https://510kreport.com/company/everyway-medical-instruments)
- Hivox Biotek, Inc.: 2 (https://510kreport.com/company/hivox-biotek)
- Newlife Sciences, LLC: 1 (https://510kreport.com/company/newlife-sciences)
- Zmi Elecronics, Ltd.: 1 (https://510kreport.com/company/zmi-elecronics)
- Savia Limited: 1 (https://510kreport.com/company/savia)
- Drtv Asia, Ltd.: 1 (https://510kreport.com/company/drtv-asia)
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)

## Its most-cited devices
- K091757: Otc Tens for Arm and Leg Pain Relief, Model WL-2407 (2010), cited by 5
- K040512: Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and WL-2401 (2004), cited by 4
- K020020: The Izzzy-Tens (WL-2401), the Slim-Tens (WL-2402), the Mens-Tens (WL2403), the Compact Tens (WL-2302) (2002), cited by 3
- K133723: Otc Patch (2014), cited by 3
- K172809: OTC Combo TENS/EMS System (2017), cited by 2
- K021359: Digi-Pro Tens Model WL-2203 and WL-2205 (2002), cited by 2

## Recent decisions
- K251760: Well-Life Incontinence Stimulation System (WL-2405i (P)) (Feb 12, 2026)
- K233054: Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator (Oct 18, 2024)
- K222528: Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode (Dec 29, 2022)
- K220524: Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) (Aug 4, 2022)
- K213091: Well-Life TENS/EMS/Heating Stimulator (Feb 19, 2022)
- K200942: Well-Life Garment Electrodes (GM Series) (Jun 1, 2021)
- K172809: OTC Combo TENS/EMS System (Oct 18, 2017)
- K162663: WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A (Jan 17, 2017)

Source page: https://510kreport.com/company/well-life-healthcare