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Hong Kong Highpower Technology Company

✅ Low Risk

FEI: 3007828776 • Tai Po • HONG KONG

FEI

FEI Number

3007828776

📍

Location

Tai Po

🇭🇰

Country

HONG KONG
🏢

Address

Flat/Rm 4, Block 4, 13/F, Tai Pin, , Tai Po, , Hong Kong

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/1/2009
Latest Refusal
12/1/2009
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3411×

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

DateProductViolationsDivision
12/1/2009
76NUWSTIMULATOR, MUSCLE, POWERED, DENTAL
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Hong Kong Highpower Technology Company's FDA import refusal history?

Hong Kong Highpower Technology Company (FEI: 3007828776) has 1 FDA import refusal record(s) in our database, spanning from 12/1/2009 to 12/1/2009.

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. Hong Kong Highpower Technology Company's FEI number is 3007828776.

What types of violations has Hong Kong Highpower Technology Company received?

Hong Kong Highpower Technology Company 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 Hong Kong Highpower Technology Company come from?

All FDA import refusal data for Hong Kong Highpower Technology Company 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.