Shenzhen Pango Electronic Co., Ltd
⚠️ Moderate Risk
FEI: 3006792041 • Shenzhen, Guangdong • CHINA
FEI Number
3006792041
Location
Shenzhen, Guangdong
Country
CHINAAddress
Xikeng Village, Henggang, No. 25 Fenghuang Road; 1st Industry Zone, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
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 |
|---|---|---|---|
| 4/16/2025 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 237NO PMA | Division of West Coast Imports (DWCI) |
| 3/6/2019 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/21/2012 | 89IPFSTIMULATOR, MUSCLE, POWERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Shenzhen Pango Electronic Co., Ltd's FDA import refusal history?
Shenzhen Pango Electronic Co., Ltd (FEI: 3006792041) has 3 FDA import refusal record(s) in our database, spanning from 3/21/2012 to 4/16/2025.
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 Pango Electronic Co., Ltd's FEI number is 3006792041.
What types of violations has Shenzhen Pango Electronic Co., Ltd received?
Shenzhen Pango Electronic Co., Ltd has been cited for 3 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 Pango Electronic Co., Ltd come from?
All FDA import refusal data for Shenzhen Pango Electronic 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.