Unified Business No.

27654740

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

6 F., No. 168, Lide St., Zhonghe Dist., New Taipei City 235602, Taiwan (R.O.C.)↗
New Taipei City (16,829) · Zhonghe Dist. (1,918)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Limited Company

Founded

2005-03-31

Paid-in capital

NT$ 5,000,000

Representative

Hsieh Chin-chih

Phone

02-22266981

Website

https://www.welllifehealthcare.com/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Individually held

North American market

FCC equipment authorization FDA 510(k) clearance FDA medical device registration Health Canada medical device licence

Representative tenure

In office since at least 2016 (10+ years)

Compliance record

FDA import refusal: 2 product(s), latest 2023-07-13

Plants 2

• Plant · 6F, No. 168, Lide St., Zhonghe Dist., New Taipei City↗ In production
• Plant 2 · 1F, No. 75, Ln. 29, Huacheng Rd., Xinzhuang Dist., New Taipei City↗ In production

Certifications 10

• Medical device license (188)Official registry Valid until 2011-02-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-08-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-09-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-02-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-02-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-09-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-07-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2013-07-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-03-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-08-27 · Taiwan Food and Drug Administration (TFDA)

North American market evidence 29

• FCC equipment authorization 2AHFH 2016-02-05
• FDA 510(k) clearance K251760 2026-02-12
  Well-Life Incontinence Stimulation System (WL-2405i(P))
• FDA 510(k) clearance K233054 2024-10-18
  Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
• FDA 510(k) clearance K222528 2022-12-29
  Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
• FDA 510(k) clearance K220524 2022-08-04
  Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
• FDA 510(k) clearance K213091 2022-02-19
  Well-Life TENS/EMS/Heating Stimulator
• FDA 510(k) clearance K200942 2021-06-01
  Well-Life Garment Electrodes (GM Series)
• FDA 510(k) clearance K172809 2017-10-18
  OTC Combo TENS/EMS System
• FDA 510(k) clearance K162663 2017-01-17
  WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
• FDA 510(k) clearance K161453 2016-12-05
  WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
• FDA 510(k) clearance K141299 2014-11-14
  OTC COMBO TENS/EMS SYSTEM
• FDA 510(k) clearance K133723 2014-01-28
  OTC PATCH
• FDA 510(k) clearance K123075 2013-07-11
  BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E
• FDA 510(k) clearance K121353 2012-09-07
  MINI PATCH
• FDA 510(k) clearance K102786 2011-07-01
  WELL-LIFE OTC EMS SYSTEM
• FDA 510(k) clearance K100399 2010-06-25
  4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
• FDA 510(k) clearance K091757 2010-02-05
  OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
• FDA 510(k) clearance K092763 2009-10-08
  IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
• FDA 510(k) clearance K090023 2009-01-30
  IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
• FDA 510(k) clearance K080304 2008-06-20
  PRO TENS, MODEL WL-240 RX
• FDA 510(k) clearance K072168 2007-12-19
  OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
• FDA 510(k) clearance K033857 2003-12-19
  T-TECH DIGITAL, MODEL WL-22XXA SERIES
• FDA 510(k) clearance K030537 2003-03-20
  DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B
• FDA 510(k) clearance K020020 2002-12-30
  THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)
• FDA 510(k) clearance K020314 2002-04-30
  DIGI-PRO TENS, MODEL WL-2204 AND WL-2205
• FDA 510(k) clearance K021359 2002-04-30
  DIGI-PRO TENS MODEL WL-2203 AND WL-2205
• FDA medical device registration 3006850006 2007-12-12 – 2026-03-27
  Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Nerve, Transcutaneous, For Pain Relief; Stimulator, Muscle, Powered, For Muscle Conditioning and more (12)
• FDA import refusal 3006850006 2019-09-09 – 2023-07-13
  ELECTRODE, CUTANEOUS; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Health Canada medical device licence 130570

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