ImportRefusal LogoImportRefusal

Zhong Shan Lebo Medical Company Limited

✅ Low Risk

FEI: 3013495708 • Zhongshan, Guangdong • CHINA

FEI

FEI Number

3013495708

📍

Location

Zhongshan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

NO. 6 Yuanxing Road, Dongsheng Town, Zhongshan, Guangdong, China

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
4/26/2021
Latest Refusal
4/26/2021
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
4/26/2021
89INPTIPS AND PADS, CANE, CRUTCH AND WALKER
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Zhong Shan Lebo Medical Company Limited's FDA import refusal history?

Zhong Shan Lebo Medical Company Limited (FEI: 3013495708) has 1 FDA import refusal record(s) in our database, spanning from 4/26/2021 to 4/26/2021.

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. Zhong Shan Lebo Medical Company Limited's FEI number is 3013495708.

What types of violations has Zhong Shan Lebo Medical Company Limited received?

Zhong Shan Lebo Medical Company Limited 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 Zhong Shan Lebo Medical Company Limited come from?

All FDA import refusal data for Zhong Shan Lebo Medical Company Limited 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.