FDA Registration
Active
🇹🇼 Taiwan
Well-Life Healthcare Limited
Reg #: 3006850006
·
FEI: 3006850006
·
Expires 2026
Products
12
Proprietary Names
87
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- Well-Life Healthcare Limited
- Registration Number
- 3006850006
- FEI Number
- 3006850006
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6F., No.168, Lide St.,
- City
- Jhonghe Taipei
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K033857
Owner / Operator
- Firm Name
- Well-Life Healthcare Limited
- Operator Number
- 10023740
- Address
- 6F., No. 168, Lide St.,
- City
- Jhonghe
- State
- Taipei
- Postal Code
- 235
- Country
- TW
- Correspondent
- Chin-Chih Hsieh
US Agent
- Business Name
- ProMedic, Inc.
- Contact Name
- Paul E. Dryden
- Address
- 131 Bay Point Dr. NE
- City
- Saint Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2007-12-12 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2007-12-12 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2022-11-15 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2022-11-15 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2014-11-18 |
| Perineometer | HIR | Class 2 | Obstetrics/Gynecology | No | 2023-05-19 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2023-05-19 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2010-07-07 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2025-11-15 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2021-12-05 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2008-12-19 |
| Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | ILX | Class 2 | Physical Medicine | No | 2025-09-17 |
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
TOP TENS, DT6030
Great Life Pro Tens
Healthy Bacs Pro Tens
PurePulse Pro
ExcelHealth iReliev Model # ET-1313
ZEWA, S21019
OTC TENS For Arm & Leg Pain Relief/Model: WL-2407
ZEWA, S21017
OTC TENS FOR LOW BACK Pain Relief /Model WL-2407
Beurer, EM39
GF Health Products, GF-9260, GF-9261
Well-Life Electrodes, CM/SP series
SP92246 -Foot
PurePulse Pro Pad , CM/SP series
i.Reliev Pad, CM/SP series
Replacement Electrodes for EM13, Model EM13RP
PLAYMAKAR Pad, CM/SP series
Well Life Wireless TENS/EMS Stimulator, Model WR-2605/WR-2605A
PlayMakar PRO Muscle Stimulator Model #PRO-1000-2
PlayMakar PRO Muscle Stimulator Model #PRO-1000
iReliev Therapeutic Wearable System, Model # ET-5050
iReliev PlayMakar Black Wireless TENS and EMS Therapeutic Wearable System Muscle Stimulator, IR-PRO-1000-2
iReliev PlayMakar Black Wireless TENS and EMS Therapeutic Wearable System Muscle Stimulator, IR-PRO-1000.
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility