O-Two Medical Technologies, Inc.
⚠️ Moderate Risk
FEI: 3002807836 • Brampton, Ontario • CANADA
FEI Number
3002807836
Location
Brampton, Ontario
Country
CANADAAddress
45A Armthorpe Road, , Brampton, Ontario, 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
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).
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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/19/2011 | 73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | 341REGISTERED | Detroit District Office (DET-DO) |
| 12/16/2009 | 77EWTDEVICE, ANTICHOKE, SUCTION | 2380NO PMA/PDP | Detroit District Office (DET-DO) |
| 8/27/2008 | 73BTMVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 1/7/2003 | 73BTMVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/29/2002 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is O-Two Medical Technologies, Inc.'s FDA import refusal history?
O-Two Medical Technologies, Inc. (FEI: 3002807836) has 5 FDA import refusal record(s) in our database, spanning from 3/29/2002 to 8/19/2011.
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. O-Two Medical Technologies, Inc.'s FEI number is 3002807836.
What types of violations has O-Two Medical Technologies, Inc. received?
O-Two Medical Technologies, 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 O-Two Medical Technologies, Inc. come from?
All FDA import refusal data for O-Two Medical Technologies, 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.