Thermotex Therapy Systems Ltd
⚠️ High Risk
FEI: 3002316112 • Calgary, Alberta • CANADA
FEI Number
3002316112
Location
Calgary, Alberta
Country
CANADAAddress
15-6115 4 St SE, , Calgary, Alberta, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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.
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 |
|---|---|---|---|
| 1/15/2010 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 1/15/2010 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 1/15/2010 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 1/15/2010 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 1/15/2010 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 1/15/2010 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 1/15/2010 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 1/15/2010 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 1/15/2010 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 12/30/2009 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 12/29/2009 | 89IRTPAD, HEATING, POWERED | Cincinnati District Office (CIN-DO) | |
| 12/28/2009 | 89IRTPAD, HEATING, POWERED | Cincinnati District Office (CIN-DO) | |
| 12/21/2009 | 89IRTPAD, HEATING, POWERED | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/19/2009 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 10/19/2009 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 9/30/2009 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 9/17/2009 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Thermotex Therapy Systems Ltd's FDA import refusal history?
Thermotex Therapy Systems Ltd (FEI: 3002316112) has 17 FDA import refusal record(s) in our database, spanning from 9/17/2009 to 1/15/2010.
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. Thermotex Therapy Systems Ltd's FEI number is 3002316112.
What types of violations has Thermotex Therapy Systems Ltd received?
Thermotex Therapy Systems Ltd 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 Thermotex Therapy Systems Ltd come from?
All FDA import refusal data for Thermotex Therapy Systems Ltd 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.