Cefaly Technology
⚠️ Moderate Risk
FEI: 3010188009 • Herstal, Liege • BELGIUM
FEI Number
3010188009
Location
Herstal, Liege
Country
BELGIUMAddress
5 ZI des Hauts Sarts, Avenue 4e, Herstal, Liege, Belgium
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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2014 | 84PCCSTIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 10/22/2014 | 84PCCSTIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE | Los Angeles District Office (LOS-DO) | |
| 7/11/2014 | 84PCCSTIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE | 2480RXPERSONAL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Cefaly Technology's FDA import refusal history?
Cefaly Technology (FEI: 3010188009) has 3 FDA import refusal record(s) in our database, spanning from 7/11/2014 to 10/30/2014.
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. Cefaly Technology's FEI number is 3010188009.
What types of violations has Cefaly Technology received?
Cefaly Technology 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 Cefaly Technology come from?
All FDA import refusal data for Cefaly Technology 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.