Everyway Medical Instruments Co., Inc.
⚠️ Moderate Risk
FEI: 3002552319 • New Taipei City • TAIWAN
FEI Number
3002552319
Location
New Taipei City
Country
TAIWANAddress
3 Fl., No. 5, Lane 155, Sec. 3, Beishen Road, Shenkeng 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
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 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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 |
|---|---|---|---|
| 8/13/2015 | 89INQTABLE, POWERED | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/22/2015 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 3/2/2011 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 223FALSE | Seattle District Office (SEA-DO) |
| 5/19/2009 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 508NO 510(K) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Everyway Medical Instruments Co., Inc.'s FDA import refusal history?
Everyway Medical Instruments Co., Inc. (FEI: 3002552319) has 4 FDA import refusal record(s) in our database, spanning from 5/19/2009 to 8/13/2015.
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. Everyway Medical Instruments Co., Inc.'s FEI number is 3002552319.
What types of violations has Everyway Medical Instruments Co., Inc. received?
Everyway Medical Instruments Co., Inc. has been cited for 4 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 Everyway Medical Instruments Co., Inc. come from?
All FDA import refusal data for Everyway Medical Instruments Co., 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.