Wah Kong Precision
⚠️ Moderate Risk
FEI: 1000352477 • Jiangmen, Guangdong • CHINA
FEI Number
1000352477
Location
Jiangmen, Guangdong
Country
CHINAAddress
133 Victory Road, , Jiangmen, 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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/30/2005 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 126FAILS STD | Cincinnati District Office (CIN-DO) |
| 8/2/2005 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Cincinnati District Office (CIN-DO) | |
| 8/2/2005 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Cincinnati District Office (CIN-DO) | |
| 8/2/2005 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Cincinnati District Office (CIN-DO) | |
| 8/2/2005 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Cincinnati District Office (CIN-DO) | |
| 7/19/2005 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Wah Kong Precision's FDA import refusal history?
Wah Kong Precision (FEI: 1000352477) has 6 FDA import refusal record(s) in our database, spanning from 7/19/2005 to 8/30/2005.
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. Wah Kong Precision's FEI number is 1000352477.
What types of violations has Wah Kong Precision received?
Wah Kong Precision has been cited for 4 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 Wah Kong Precision come from?
All FDA import refusal data for Wah Kong Precision 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.