Medical Equipment Of Korea
⚠️ Moderate Risk
FEI: 3004088606 • Kangwondo • SOUTH KOREA
FEI Number
3004088606
Location
Kangwondo
Country
SOUTH KOREAAddress
861-10 Taeqyedong Chunchonsi, , Kangwondo, , South Korea
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
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).
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/27/2005 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 1/27/2005 | 80KMIMONITOR, BED PATIENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/31/2004 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | Los Angeles District Office (LOS-DO) | |
| 8/31/2004 | 85MMAOXIMETER, FETAL PULSE | 237NO PMA | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Medical Equipment Of Korea's FDA import refusal history?
Medical Equipment Of Korea (FEI: 3004088606) has 4 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 1/27/2005.
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. Medical Equipment Of Korea's FEI number is 3004088606.
What types of violations has Medical Equipment Of Korea received?
Medical Equipment Of Korea has been cited for 3 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 Medical Equipment Of Korea come from?
All FDA import refusal data for Medical Equipment Of Korea 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.