International Tv Concepts Ltd.
⚠️ Moderate Risk
FEI: 3003399788 • Tsim Sha Tsui, Kowloon • HONG KONG
FEI Number
3003399788
Location
Tsim Sha Tsui, Kowloon
Country
HONG KONGAddress
Room 2014, 15, Concordia Plaza; 1 Science Museum Road, Tsim Sha Tsui, Kowloon, Hong Kong
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).
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).
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 |
|---|---|---|---|
| 1/23/2002 | 84GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/12/2001 | 89LBFDEVICE, THERAPY, DIRECT CURRENT, LOW INTENSITY | 237NO PMA | Florida District Office (FLA-DO) |
| 10/12/2001 | 85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is International Tv Concepts Ltd.'s FDA import refusal history?
International Tv Concepts Ltd. (FEI: 3003399788) has 3 FDA import refusal record(s) in our database, spanning from 10/12/2001 to 1/23/2002.
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. International Tv Concepts Ltd.'s FEI number is 3003399788.
What types of violations has International Tv Concepts Ltd. received?
International Tv Concepts Ltd. 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 International Tv Concepts Ltd. come from?
All FDA import refusal data for International Tv Concepts 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.