Jawon Medical Co Ltd
✅ Low Risk
FEI: 3003180294 • Kyung Sang Bukdo • SOUTH KOREA
FEI Number
3003180294
Location
Kyung Sang Bukdo
Country
SOUTH KOREAAddress
13 Lot, 21 Block Jinryang Industrial, , Kyung Sang Bukdo, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2007 | 74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Jawon Medical Co Ltd's FDA import refusal history?
Jawon Medical Co Ltd (FEI: 3003180294) has 1 FDA import refusal record(s) in our database, spanning from 4/25/2007 to 4/25/2007.
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. Jawon Medical Co Ltd's FEI number is 3003180294.
What types of violations has Jawon Medical Co Ltd received?
Jawon Medical Co Ltd has been cited for 1 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 Jawon Medical Co Ltd come from?
All FDA import refusal data for Jawon Medical Co Ltd 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.