Sound Medical Corp.
⚠️ Moderate Risk
FEI: 3004648164 • Nan-Tou City • TAIWAN
FEI Number
3004648164
Location
Nan-Tou City
Country
TAIWANAddress
C/O No.11 Tsu-Chiang 1st Rd.Nan-Kang, , Nan-Tou City, , Taiwan
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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/15/2005 | 89IOYSUPPORT, ARM | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 89ITQJOINT, KNEE, EXTERNAL BRACE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 89ITQJOINT, KNEE, EXTERNAL BRACE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 80KYSINSOLES, MEDICAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sound Medical Corp.'s FDA import refusal history?
Sound Medical Corp. (FEI: 3004648164) has 4 FDA import refusal record(s) in our database, spanning from 10/15/2005 to 10/15/2005.
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. Sound Medical Corp.'s FEI number is 3004648164.
What types of violations has Sound Medical Corp. received?
Sound Medical Corp. 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 Sound Medical Corp. come from?
All FDA import refusal data for Sound Medical Corp. 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.