ImportRefusal LogoImportRefusal

FUAN HEALTH FOREVER ELECTRONICS CO.,LTD

✅ Low Risk

FEI: 3014213804 • Fujian, fuan • CHINA

FEI

FEI Number

3014213804

📍

Location

Fujian, fuan

🇨🇳

Country

CHINA
🏢

Address

No. 10, Guanzhuang West Road, Chengnan Street, , Fujian, fuan, China

Low Risk

FDA Import Risk Assessment

18.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/18/2022
Latest Refusal
5/18/2022
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
12.9×20%
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
5/18/2022
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is FUAN HEALTH FOREVER ELECTRONICS CO.,LTD's FDA import refusal history?

FUAN HEALTH FOREVER ELECTRONICS CO.,LTD (FEI: 3014213804) has 1 FDA import refusal record(s) in our database, spanning from 5/18/2022 to 5/18/2022.

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. FUAN HEALTH FOREVER ELECTRONICS CO.,LTD's FEI number is 3014213804.

What types of violations has FUAN HEALTH FOREVER ELECTRONICS CO.,LTD received?

FUAN HEALTH FOREVER ELECTRONICS CO.,LTD 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 FUAN HEALTH FOREVER ELECTRONICS CO.,LTD come from?

All FDA import refusal data for FUAN HEALTH FOREVER ELECTRONICS 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.