Medical Compression Systems DBN Ltd.
⚠️ Moderate Risk
FEI: 3003715046 • Or Akiva, HEVA • ISRAEL
FEI Number
3003715046
Location
Or Akiva, HEVA
Country
ISRAELAddress
2, Ha-Ilan, , Or Akiva, HEVA, Israel
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/31/2010 | 74JOWSLEEVE, LIMB, COMPRESSIBLE | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 12/15/2005 | 89IRPMASSAGER, POWERED INFLATABLE TUBE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/15/2005 | 74JOWSLEEVE, LIMB, COMPRESSIBLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/15/2005 | 89IRPMASSAGER, POWERED INFLATABLE TUBE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Medical Compression Systems DBN Ltd.'s FDA import refusal history?
Medical Compression Systems DBN Ltd. (FEI: 3003715046) has 4 FDA import refusal record(s) in our database, spanning from 12/15/2005 to 3/31/2010.
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. Medical Compression Systems DBN Ltd.'s FEI number is 3003715046.
What types of violations has Medical Compression Systems DBN Ltd. received?
Medical Compression Systems DBN 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 Medical Compression Systems DBN Ltd. come from?
All FDA import refusal data for Medical Compression Systems DBN 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.