EASY POWER LTD.
✅ Low Risk
FEI: 1000406329 • Kowloon Bay, Kowloon • HONG KONG
FEI Number
1000406329
Location
Kowloon Bay, Kowloon
Country
HONG KONGAddress
17 WANG HOI RD, Unit 11, 12th Fl., Shun Fat Industrial Building, Kowloon Bay, Kowloon, Hong Kong
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 |
|---|---|---|---|
| 3/20/2017 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is EASY POWER LTD.'s FDA import refusal history?
EASY POWER LTD. (FEI: 1000406329) has 1 FDA import refusal record(s) in our database, spanning from 3/20/2017 to 3/20/2017.
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. EASY POWER LTD.'s FEI number is 1000406329.
What types of violations has EASY POWER LTD. received?
EASY POWER 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 EASY POWER LTD. come from?
All FDA import refusal data for EASY POWER 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.