ImportRefusal LogoImportRefusal

Shenzhen Betterkong Electronic Co Ltd

✅ Low Risk

FEI: 3010495712 • Shenzhen • CHINA

FEI

FEI Number

3010495712

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

Wan'an Road Industrial Park, Shajing, Bao'an District, Shenzhen, , China

Low Risk

FDA Import Risk Assessment

18.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
12/20/2013
Latest Refusal
12/20/2013
Earliest Refusal

Score Breakdown

Violation Severity
35.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
12/20/2013
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
333LACKS FIRM
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Shenzhen Betterkong Electronic Co Ltd's FDA import refusal history?

Shenzhen Betterkong Electronic Co Ltd (FEI: 3010495712) has 1 FDA import refusal record(s) in our database, spanning from 12/20/2013 to 12/20/2013.

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. Shenzhen Betterkong Electronic Co Ltd's FEI number is 3010495712.

What types of violations has Shenzhen Betterkong Electronic Co Ltd received?

Shenzhen Betterkong Electronic Co Ltd 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 Shenzhen Betterkong Electronic Co Ltd come from?

All FDA import refusal data for Shenzhen Betterkong Electronic 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.