Power Kit Medical Co., LTD.
✅ Low Risk
FEI: 3017207751 • Wuhan, Hubei • CHINA
FEI Number
3017207751
Location
Wuhan, Hubei
Country
CHINAAddress
No. 777 Optic Valley 3rd Road,Wuhan Eastlake , New & High Technology Development Zone, , Wuhan, Hubei, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/27/2021 | 79OHOFIRST AID KIT WITHOUT DRUG | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Power Kit Medical Co., LTD.'s FDA import refusal history?
Power Kit Medical Co., LTD. (FEI: 3017207751) has 1 FDA import refusal record(s) in our database, spanning from 8/27/2021 to 8/27/2021.
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. Power Kit Medical Co., LTD.'s FEI number is 3017207751.
What types of violations has Power Kit Medical Co., LTD. received?
Power Kit Medical Co., LTD. 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 Power Kit Medical Co., LTD. come from?
All FDA import refusal data for Power Kit Medical 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.