Dongguan Ageless Health Industrial Ltd. (China)
⚠️ Moderate Risk
FEI: 3010299870 • Dongguan, Guangdong • CHINA
FEI Number
3010299870
Location
Dongguan, Guangdong
Country
CHINAAddress
Building A1, 3 Rd Floor; Changping Simacun Madongshen Industrial Area, Dongguan, 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 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 |
|---|---|---|---|
| 8/21/2019 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Dongguan Ageless Health Industrial Ltd. (China)'s FDA import refusal history?
Dongguan Ageless Health Industrial Ltd. (China) (FEI: 3010299870) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2019 to 8/21/2019.
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. Dongguan Ageless Health Industrial Ltd. (China)'s FEI number is 3010299870.
What types of violations has Dongguan Ageless Health Industrial Ltd. (China) received?
Dongguan Ageless Health Industrial Ltd. (China) 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 Dongguan Ageless Health Industrial Ltd. (China) come from?
All FDA import refusal data for Dongguan Ageless Health Industrial Ltd. (China) 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.