Phoenix Em
⚠️ Moderate Risk
FEI: 3007041119 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3007041119
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Carrera 32 No 89-22, , Bogota, Cundinamarca, Colombia
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/25/2008 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/25/2008 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/25/2008 | 97RALMASSAGER, ULTRASONIC NON-MEDICAL DEVICES | 47NON STD | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Phoenix Em's FDA import refusal history?
Phoenix Em (FEI: 3007041119) has 3 FDA import refusal record(s) in our database, spanning from 8/25/2008 to 8/25/2008.
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. Phoenix Em's FEI number is 3007041119.
What types of violations has Phoenix Em received?
Phoenix Em has been cited for 2 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 Phoenix Em come from?
All FDA import refusal data for Phoenix Em 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.