Zhoulin Bio Spectrum Tech Inc
⚠️ Moderate Risk
FEI: 3004035326 • Beijing, Beijing • CHINA
FEI Number
3004035326
Location
Beijing, Beijing
Country
CHINAAddress
Maolin Ju, , Beijing, Beijing, 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 |
|---|---|---|---|
| 8/25/2003 | 89LBFDEVICE, THERAPY, DIRECT CURRENT, LOW INTENSITY | 508NO 510(K) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Zhoulin Bio Spectrum Tech Inc's FDA import refusal history?
Zhoulin Bio Spectrum Tech Inc (FEI: 3004035326) has 1 FDA import refusal record(s) in our database, spanning from 8/25/2003 to 8/25/2003.
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. Zhoulin Bio Spectrum Tech Inc's FEI number is 3004035326.
What types of violations has Zhoulin Bio Spectrum Tech Inc received?
Zhoulin Bio Spectrum Tech Inc 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 Zhoulin Bio Spectrum Tech Inc come from?
All FDA import refusal data for Zhoulin Bio Spectrum Tech Inc 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.