MAXHEALTH CORP.
⚠️ Moderate Risk
FEI: 3004839326 • New Taipei City • TAIWAN
FEI Number
3004839326
Location
New Taipei City
Country
TAIWANAddress
No. 99, Section 1, 14 F; Xintai 5th Road , Xizhi District, New Taipei 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).
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 |
|---|---|---|---|
| 3/5/2005 | 89IMLARMREST, WHEELCHAIR | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 11/8/2004 | 89IMMFOOTREST, WHEELCHAIR | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 4/18/2003 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/18/2003 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Los Angeles District Office (LOS-DO) | |
| 2/28/2002 | 89INPTIPS AND PADS, CANE, CRUTCH AND WALKER | 341REGISTERED | Detroit District Office (DET-DO) |
| 2/28/2002 | 89ILSADAPTOR, HYGIENE | 341REGISTERED | Detroit District Office (DET-DO) |
| 2/28/2002 | 89ILSADAPTOR, HYGIENE | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is MAXHEALTH CORP.'s FDA import refusal history?
MAXHEALTH CORP. (FEI: 3004839326) has 7 FDA import refusal record(s) in our database, spanning from 2/28/2002 to 3/5/2005.
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. MAXHEALTH CORP.'s FEI number is 3004839326.
What types of violations has MAXHEALTH CORP. received?
MAXHEALTH 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 MAXHEALTH CORP. come from?
All FDA import refusal data for MAXHEALTH 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.