Microtransponder Inc.
⚠️ High Risk
FEI: 3012309950 • Austin, TX • UNITED STATES
FEI Number
3012309950
Location
Austin, TX
Country
UNITED STATESAddress
2802 Flintrock Trce Ste 226, , Austin, TX, United States
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/2/2025 | 89QPYSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR STROKE REHABILITATION | 237NO PMA | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Microtransponder Inc.'s FDA import refusal history?
Microtransponder Inc. (FEI: 3012309950) has 1 FDA import refusal record(s) in our database, spanning from 9/2/2025 to 9/2/2025.
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. Microtransponder Inc.'s FEI number is 3012309950.
What types of violations has Microtransponder Inc. received?
Microtransponder Inc. has been cited for 1 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 Microtransponder Inc. come from?
All FDA import refusal data for Microtransponder 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.