Alberta Hearing Aid Svc
✅ Low Risk
FEI: 1000540558 • Edmonton, AB • CANADA
FEI Number
1000540558
Location
Edmonton, AB
Country
CANADAAddress
10611 Kingsway Ave, , Edmonton, AB, Canada
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 |
|---|---|---|---|
| 5/10/2002 | 77KHLHEARING-AID, MASTER | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Alberta Hearing Aid Svc's FDA import refusal history?
Alberta Hearing Aid Svc (FEI: 1000540558) has 1 FDA import refusal record(s) in our database, spanning from 5/10/2002 to 5/10/2002.
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. Alberta Hearing Aid Svc's FEI number is 1000540558.
What types of violations has Alberta Hearing Aid Svc received?
Alberta Hearing Aid Svc 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 Alberta Hearing Aid Svc come from?
All FDA import refusal data for Alberta Hearing Aid Svc 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.