Hearking Electronics Tech Co Ltd
⚠️ Moderate Risk
FEI: 3009017486 • Shenzhen, Guangdong • CHINA
FEI Number
3009017486
Location
Shenzhen, Guangdong
Country
CHINAAddress
NO 58 Qianjinlu, Longgang, Shenzhen, Guangdong, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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 |
|---|---|---|---|
| 4/2/2012 | 76MGEHEARING-AID, AUDIODONTIC | Division of Southeast Imports (DSEI) | |
| 8/11/2011 | 76MGEHEARING-AID, AUDIODONTIC | Division of Southeast Imports (DSEI) | |
| 8/11/2011 | 76MGEHEARING-AID, AUDIODONTIC | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Hearking Electronics Tech Co Ltd's FDA import refusal history?
Hearking Electronics Tech Co Ltd (FEI: 3009017486) has 3 FDA import refusal record(s) in our database, spanning from 8/11/2011 to 4/2/2012.
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. Hearking Electronics Tech Co Ltd's FEI number is 3009017486.
What types of violations has Hearking Electronics Tech Co Ltd received?
Hearking Electronics Tech Co Ltd has been cited for 2 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 Hearking Electronics Tech Co Ltd come from?
All FDA import refusal data for Hearking Electronics Tech 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.