Parasym OU
⚠️ High Risk
FEI: 3027815163 • Tallinn • ESTONIA
FEI Number
3027815163
Location
Tallinn
Country
ESTONIAAddress
Majaka 26, 11412, , Tallinn, , Estonia
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2025 | 84PKRNON-INVASIVE VAGUS NERVE STIMULATOR - HEADACHE | Division of Southeast Imports (DSEI) | |
| 9/26/2024 | 73BXMSTIMULATOR, NERVE, AC-POWERED | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/4/2024 | 73BXMSTIMULATOR, NERVE, AC-POWERED | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/27/2024 | 84GZISTIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/13/2024 | 84PKRNON-INVASIVE VAGUS NERVE STIMULATOR - HEADACHE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/13/2024 | 84PKRNON-INVASIVE VAGUS NERVE STIMULATOR - HEADACHE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/12/2023 | 84PKRNON-INVASIVE VAGUS NERVE STIMULATOR - HEADACHE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Parasym OU's FDA import refusal history?
Parasym OU (FEI: 3027815163) has 7 FDA import refusal record(s) in our database, spanning from 9/12/2023 to 2/28/2025.
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. Parasym OU's FEI number is 3027815163.
What types of violations has Parasym OU received?
Parasym OU 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 Parasym OU come from?
All FDA import refusal data for Parasym OU 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.