Shenzhen Kangerbo Medical Technology Co., Ltd
✅ Low Risk
FEI: 3008602381 • Shenzhen, Guangdong • CHINA
FEI Number
3008602381
Location
Shenzhen, Guangdong
Country
CHINAAddress
Block A E F/20, Binfen Century, 99 Chenguang Road, Shenzhen, Guangdong, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 1/7/2013 | 91DJZDEVICES, BREATH TRAPPING, ALCOHOL | 333LACKS FIRM | Cincinnati District Office (CIN-DO) |
| 12/12/2012 | 73BWKSTIMULATOR, ELECTRO-ACUPUNCTURE | Cincinnati District Office (CIN-DO) | |
| 11/9/2010 | 74DXQCUFF, BLOOD-PRESSURE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Shenzhen Kangerbo Medical Technology Co., Ltd's FDA import refusal history?
Shenzhen Kangerbo Medical Technology Co., Ltd (FEI: 3008602381) has 3 FDA import refusal record(s) in our database, spanning from 11/9/2010 to 1/7/2013.
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. Shenzhen Kangerbo Medical Technology Co., Ltd's FEI number is 3008602381.
What types of violations has Shenzhen Kangerbo Medical Technology Co., Ltd received?
Shenzhen Kangerbo Medical Technology Co., Ltd 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 Shenzhen Kangerbo Medical Technology Co., Ltd come from?
All FDA import refusal data for Shenzhen Kangerbo Medical Technology 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.