Unicare Medical Inc.
⚠️ Moderate Risk
FEI: 3003447459 • North York, ON • CANADA
FEI Number
3003447459
Location
North York, ON
Country
CANADAAddress
770 Lawrence Ave W, , North York, ON, Canada
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/23/2002 | 89ITIWHEELCHAIR, POWERED | New York District Office (NYK-DO) | |
| 9/5/2002 | 89ITIWHEELCHAIR, POWERED | New York District Office (NYK-DO) | |
| 9/5/2002 | 89ITIWHEELCHAIR, POWERED | New York District Office (NYK-DO) | |
| 7/11/2002 | 80LLIBED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE | Detroit District Office (DET-DO) | |
| 7/11/2002 | 80LLIBED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE | 118NOT LISTED | Detroit District Office (DET-DO) |
| 5/9/2002 | 89INOCHAIR, POSITIONING, ELECTRIC | Detroit District Office (DET-DO) | |
| 2/28/2002 | 89ILSADAPTOR, HYGIENE | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Unicare Medical Inc.'s FDA import refusal history?
Unicare Medical Inc. (FEI: 3003447459) has 7 FDA import refusal record(s) in our database, spanning from 2/28/2002 to 9/23/2002.
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. Unicare Medical Inc.'s FEI number is 3003447459.
What types of violations has Unicare Medical Inc. received?
Unicare Medical Inc. 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 Unicare Medical Inc. come from?
All FDA import refusal data for Unicare Medical Inc. 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.