Danyang Jumao Physical Equipment Co Ltd
⚠️ Moderate Risk
FEI: 3006129259 • Zhenjiang, Jiangsu • CHINA
FEI Number
3006129259
Location
Zhenjiang, Jiangsu
Country
CHINAAddress
89 Shuang Feng Road, Danyang, Zhenjiang, Jiangsu, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/26/2009 | 89IORWHEELCHAIR, MECHANICAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Danyang Jumao Physical Equipment Co Ltd's FDA import refusal history?
Danyang Jumao Physical Equipment Co Ltd (FEI: 3006129259) has 1 FDA import refusal record(s) in our database, spanning from 5/26/2009 to 5/26/2009.
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. Danyang Jumao Physical Equipment Co Ltd's FEI number is 3006129259.
What types of violations has Danyang Jumao Physical Equipment Co Ltd received?
Danyang Jumao Physical Equipment 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 Danyang Jumao Physical Equipment Co Ltd come from?
All FDA import refusal data for Danyang Jumao Physical Equipment 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.