Max Concept Technology Ltd.
⚠️ Moderate Risk
FEI: 3003622625 • North Point, Hong Kong Island • HONG KONG
FEI Number
3003622625
Location
North Point, Hong Kong Island
Country
HONG KONGAddress
16/F, 1601/Flat, Kodak House Kodak House Ii; No. 39 Healthy Street East; Kwun Tong, North Point, Hong Kong Island, 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).
STD LABEL
The article appears to not bear labeling prescribed by the performance standard established under section 514.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/5/2007 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | San Francisco District Office (SAN-DO) | |
| 5/15/2002 | 84GYBMEDIA, ELECTROCONDUCTIVE | Florida District Office (FLA-DO) | |
| 5/15/2002 | 84GYBMEDIA, ELECTROCONDUCTIVE | 237NO PMA | Florida District Office (FLA-DO) |
| 5/15/2002 | 89IPFSTIMULATOR, MUSCLE, POWERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Max Concept Technology Ltd.'s FDA import refusal history?
Max Concept Technology Ltd. (FEI: 3003622625) has 4 FDA import refusal record(s) in our database, spanning from 5/15/2002 to 2/5/2007.
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. Max Concept Technology Ltd.'s FEI number is 3003622625.
What types of violations has Max Concept Technology Ltd. received?
Max Concept Technology Ltd. has been cited for 6 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 Max Concept Technology Ltd. come from?
All FDA import refusal data for Max Concept Technology 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.