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Well-Life Healthcare Limited

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30068500063006850006Well-Life Healthcare Limited1N2026-01-016F., No.168, Lide St., Jhonghe Taipei TW 235

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
778931717723009K251760Well-Life Incontinence Stimulation System (WL-2405i(P))KPI2026-02-12
778931908800491K233054Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus StimulatorNUH2024-10-18
778932014315355K222528Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe ElectrodeKPI2022-12-29
778931754803915K220524Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)NUH2022-08-04
778931638194378K213091Well-Life TENS/EMS/Heating StimulatorNUH2022-02-19
778931875409119K200942Well-Life Garment Electrodes (GM Series)GXY2021-06-01
778931532246937K182581PlayMakar Sport Muscle Stimulator, Model PRO-500NUH2018-11-21
778931747193738K162663WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605AGZJ2017-01-17
778931635124556K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605ANUH2016-12-05
778932023646860K141299OTC COMBO TENS/EMS SYSTEMNUH2014-11-14
778932070268041K133723OTC PATCHNUH2014-01-28
778931636666102K121353MINI PATCHNUH2012-09-07
778932047854487K1003994 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504AGZJ2010-06-25
778931204624592K092763IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206DLIH2009-10-08
778931123017438K091757OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407NUH2010-02-05
778931802111009K082065WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SPGXY2009-04-10
778931246941506K080304PRO TENS, MODEL WL-240 RXGZJ2008-06-20
778931829044221K063660OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407NUH2007-02-07
778931873091847K052785OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406NUH2006-03-17
778931795165428K050847IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206AIPF2005-06-17
778931711310913K040512LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401GZJ2004-05-27
778931396452980K033857T-TECH DIGITAL, MODEL WL-22XXA SERIESGZJ2003-12-19
778931820300607K022494HOME CARE JELLYGYB2002-12-02
778931102997407K013768POWERED MUSCLE STIMULATORIPF2002-07-03
778931195127512K002874WELL-TENSGZJ2001-07-27
778931060658327
778931075781727
778931214831615
778931971136626

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NUH112024-10-18
GZJ72017-01-17
KPI22026-02-12
GXY22021-06-01
IPF22005-06-17
LIH12009-10-08
GYB12002-12-02

PMN#

OTC PATCH

2014-01-28

WELL-LIFE HEALTHCARE LIMITED

GUDID#

Well-Life - The WL-2405K+ is a digital electrical and heat stimulator for active treatment application as the following.TENS can be used for the following applications:- For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due tostrain from exercise or normal household and work activities.EMS can be used for the following applications:- For healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.Heat Mode:- Heat can be used for temporary relief of minor aches and pains.

WELL-LIFE HEALTHCARE LTD.

2026-03-30

Well-Life - The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relieffrom sore and aching muscles in the shoulders, waist, back, neck, upper extremities (arms), and lower extremities (legs)due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea(menstrual cramps) when used with over-the-counter pain medication.Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitatemuscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable painand relief from pain associated with arthritis (select TENS mode P8).

WELL-LIFE HEALTHCARE LTD.

2026-03-30

WELL-LIFE - For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities ( arm and/or leg) due to strain from exercise or normal household and work activities.(Choose TENS Modes P1 through P7)For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. ( Choose TENS Modes P8)For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. ( Choose EMS Modes P1 through P6)

WELL-LIFE HEALTHCARE LTD.

2017-04-25