Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006850006

FEI Number

3006850006

Entity Name

Well-Life Healthcare Limited

City/State/Country

Jhonghe Taipei, TW

Establishment Address

6F., No.168, Lide St.,, Jhonghe Taipei 235, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Well-Life Healthcare Limited (Owner Number: 10023740)

Owner / Operator Contact Address

6F., No. 168, Lide St.,, Jhonghe, TW-TPE 235, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251760

PMA Number

N/A

All Registered Proprietary Names

GF, GF TX5 TENS, TX5 EMS Well-Life Digital Tens, WL-2203, WL-2204, WL-2205 Well-Life Mini TENS Stimulator WL-2405 OTC Combo TENS/EMS System PurePulse Duo iReliev Strength & Recovery System, ET-7070 OTC COMBO tens/ems system, Model no. WL-2405 Well-Life Probe electrode DT-PROBE-V-1 SA-2687 SA-19108 DT-PROBE-A-2 SA-2486 SA-2876 DT-PROBE-V-2 DT-PROBE-V-3 SA-1483 DT-PROBE-A-1 SA-25145 SA-20100 SA-1563 SA-3478 Discount TENS Probe Electrode Well-Life Rx Wireless TENS/EMS Stimulator OTC Combo TENS/EMS System, model WL-2405G & WL-2405H PlayMakar, Model Pro-500 ZEWA, S21005 ZEWA, S21010 4 Channels Multiple Modes Digital Electrical Stimulator /WL-2504A Moist Electric Heating Pad Forever Back Plus VIVA OTC MINI TENS VERIDIAN, MODEL 22-020 Ttech Cube, Model:WL-2406 OTC TENS FOR LOW BACK Pain Relief /Model WL-2406 Well-Life OTC Patch, model:WL-2406 WL-2406 OTC Patch (Mini) VERIDIAN, Model 22-031 Bilt-Rite Part#10-65005 EM13 Well-Life OTC Patch, Model: WL-2406 Well-Life Garment Electrodes (GM Series) Hi-Dow TENS WL-2407Rx Theratech, i-TENS 2202,2201-Stering i-TENS PDC Restorer MINI PATCH, MODEL WL-2301A & WL-2301B VERIDIAN, Model 22-030 BeautyKo, Model BK#0078 X-Trim Aurawave Mini GF, GF-3,GF-3T,LUMI TENS, SW-1000, 2000-T Mettler, ME210, ME210T Well-Life Analog TENS, WL-2101A, WL-2102A, WL-2103A Thereatech , 203 Elite,2105N-Kit,2103(Re)/4460.S Alimed, RM8216 ZEWA,S21004 2103(Re)/4460.S Bilt-Rite Orthopedics (Part# 10-65001) Well-life Electrode Lead wire ComfortQuest, CP-M3, CP-P3 OTC TENS models /Model WL-2402, WL-2403, WL-2401 VIVA OTC TENS Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator Well-Life TENS EMS Heating Stimulator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2007-12-12
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2007-12-12
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2022-11-15
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2022-11-15
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2014-11-18
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2014-11-18
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2014-11-18
HIR	Perineometer	Obstetrics/Gynecology	Class 2	884.1425	2023-05-19
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2023-05-19
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2017-02-19
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2017-02-19
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2017-10-22
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2017-10-22
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-10-22
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2010-07-07
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2010-07-07
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2010-07-07
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2025-11-15
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2007-12-12
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2014-02-07
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2021-12-05
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-06-23
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2012-09-10
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2007-12-12
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2008-12-19
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2007-12-12
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2025-09-11
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-09-11
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-09-11
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2022-11-15
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2022-11-15
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2022-11-15
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2025-09-17
ILX	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5290	2025-09-17
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2026-03-27

Official Correspondent

Chin-Chih Hsieh

US Agent Details

Paul E. Dryden Business: ProMedic, Inc. Email: Matt.Dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

Well-Life Healthcare Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04
K964028	Mettler Electronics Corp.	SYS STIM 226	1997-02-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006850006. Last updated year: 2026. Please use registration number 3006850006 when referencing this establishment in official correspondence.