Well-Life Healthcare Limited
⚠️ Moderate Risk
FEI: 3006850006 • New Taipei City • TAIWAN
FEI Number
3006850006
Location
New Taipei City
Country
TAIWANAddress
Jhonghe District, No. 168, 6 F; Lide St.; Zhonghe Dist., New Taipei City, , Taiwan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/13/2023 | 84GXYELECTRODE, CUTANEOUS | Division of Southeast Imports (DSEI) | |
| 3/9/2023 | 84GXYELECTRODE, CUTANEOUS | Division of Southeast Imports (DSEI) | |
| 9/9/2019 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/6/2013 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/2/2013 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Well-Life Healthcare Limited's FDA import refusal history?
Well-Life Healthcare Limited (FEI: 3006850006) has 5 FDA import refusal record(s) in our database, spanning from 1/2/2013 to 7/13/2023.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Well-Life Healthcare Limited's FEI number is 3006850006.
What types of violations has Well-Life Healthcare Limited received?
Well-Life Healthcare Limited has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Well-Life Healthcare Limited come from?
All FDA import refusal data for Well-Life Healthcare Limited is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.