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Ehm Rehab Tech Inc

⚠️ Moderate Risk

FEI: 3005103328 • Etobicoke, ON • CANADA

FEI

FEI Number

3005103328

📍

Location

Etobicoke, ON

🇨🇦

Country

CANADA
🏢

Address

1-1570 Kipling Ave, , Etobicoke, ON, Canada

Moderate Risk

FDA Import Risk Assessment

32.6
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
10/12/2005
Latest Refusal
6/30/2005
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

5082×

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.

1181×

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).

Refusal History

DateProductViolationsDivision
10/12/2005
84NHHDEVICE, DISCHARGE, ELECTROSTATIC (FOR PAIN RELIEF)
118NOT LISTED
508NO 510(K)
Detroit District Office (DET-DO)
6/30/2005
84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ehm Rehab Tech Inc's FDA import refusal history?

Ehm Rehab Tech Inc (FEI: 3005103328) has 2 FDA import refusal record(s) in our database, spanning from 6/30/2005 to 10/12/2005.

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. Ehm Rehab Tech Inc's FEI number is 3005103328.

What types of violations has Ehm Rehab Tech Inc received?

Ehm Rehab Tech Inc 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 Ehm Rehab Tech Inc come from?

All FDA import refusal data for Ehm Rehab Tech 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.