Vigen Medical Co
✅ Low Risk
FEI: 3003982592 • Ansung • SOUTH KOREA
FEI Number
3003982592
Location
Ansung
Country
SOUTH KOREAAddress
2821 Seungdu-Ri,Gongdo-Eup, , Ansung, , South Korea
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/12/2007 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 4/12/2007 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 6/18/2003 | 89JFBTABLE, PHYSICAL THERAPY, MULTI FUNCTION | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Vigen Medical Co's FDA import refusal history?
Vigen Medical Co (FEI: 3003982592) has 3 FDA import refusal record(s) in our database, spanning from 6/18/2003 to 4/12/2007.
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. Vigen Medical Co's FEI number is 3003982592.
What types of violations has Vigen Medical Co received?
Vigen Medical Co has been cited for 2 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 Vigen Medical Co come from?
All FDA import refusal data for Vigen Medical Co 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.