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SEOHUNG Mechanism Techniquer

⚠️ Moderate Risk

FEI: 3003760871 • unknown • SOUTH KOREA

FEI

FEI Number

3003760871

📍

Location

unknown

🇰🇷
🏢

Address

unknown, , unknown, , South Korea

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
9/13/2002
Latest Refusal
9/13/2002
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

3412×

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).

5082×

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.

Refusal History

DateProductViolationsDivision
9/13/2002
87HTMSTIMULATOR, OSTEOGENESIS, ELECTRIC, BATTERY-OPERATED, INVASIVE
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
9/13/2002
87HTMSTIMULATOR, OSTEOGENESIS, ELECTRIC, BATTERY-OPERATED, INVASIVE
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is SEOHUNG Mechanism Techniquer's FDA import refusal history?

SEOHUNG Mechanism Techniquer (FEI: 3003760871) has 2 FDA import refusal record(s) in our database, spanning from 9/13/2002 to 9/13/2002.

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. SEOHUNG Mechanism Techniquer's FEI number is 3003760871.

What types of violations has SEOHUNG Mechanism Techniquer received?

SEOHUNG Mechanism Techniquer 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 SEOHUNG Mechanism Techniquer come from?

All FDA import refusal data for SEOHUNG Mechanism Techniquer 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.