HANSOL MEDICAL
⚠️ Moderate Risk
FEI: 2000023021 • KYOUNG GI-DO, KR-41 • SOUTH KOREA
FEI Number
2000023021
Location
KYOUNG GI-DO, KR-41
Country
SOUTH KOREAAddress
344-2 YOUNG TAI RI, WOL RONG MYUN PAJU CITY KYOUNG GI-DO Kor, KYOUNG GI-DO, KR-41, South Korea
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.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/9/2014 | 89KNMDEVICE, PRESSURE APPLYING | 2380NO PMA/PDP | Los Angeles District Office (LOS-DO) |
| 1/9/2014 | 89KNMDEVICE, PRESSURE APPLYING | Los Angeles District Office (LOS-DO) | |
| 1/9/2014 | 89KNMDEVICE, PRESSURE APPLYING | Los Angeles District Office (LOS-DO) | |
| 1/9/2014 | 89KNMDEVICE, PRESSURE APPLYING | Los Angeles District Office (LOS-DO) | |
| 1/9/2014 | 89KNMDEVICE, PRESSURE APPLYING | Los Angeles District Office (LOS-DO) | |
| 1/9/2014 | 89KNMDEVICE, PRESSURE APPLYING | Los Angeles District Office (LOS-DO) | |
| 1/9/2014 | 89KNMDEVICE, PRESSURE APPLYING | Los Angeles District Office (LOS-DO) | |
| 1/9/2014 | 89KNMDEVICE, PRESSURE APPLYING | Los Angeles District Office (LOS-DO) | |
| 10/10/2011 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Los Angeles District Office (LOS-DO) | |
| 3/17/2010 | 89IRTPAD, HEATING, POWERED | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 3/17/2010 | 84MVVDEVICE, ACUPRESSURE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is HANSOL MEDICAL's FDA import refusal history?
HANSOL MEDICAL (FEI: 2000023021) has 11 FDA import refusal record(s) in our database, spanning from 3/17/2010 to 1/9/2014.
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. HANSOL MEDICAL's FEI number is 2000023021.
What types of violations has HANSOL MEDICAL received?
HANSOL MEDICAL has been cited for 7 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 HANSOL MEDICAL come from?
All FDA import refusal data for HANSOL MEDICAL 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.