Hansol Medical
⚠️ Moderate Risk
FEI: 3005417950 • Paju-si, Gyeonggi-do • SOUTH KOREA
FEI Number
3005417950
Location
Paju-si, Gyeonggi-do
Country
SOUTH KOREAAddress
89-12 Tongilro620beon-Gil, Weolrong-myeon, Paju-si, Gyeonggi-do, 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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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).
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/6/2024 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | Division of West Coast Imports (DWCI) | |
| 1/12/2021 | 89KNMDEVICE, PRESSURE APPLYING | Division of West Coast Imports (DWCI) | |
| 1/12/2021 | 89KNMDEVICE, PRESSURE APPLYING | Division of West Coast Imports (DWCI) | |
| 1/12/2021 | 89KNMDEVICE, PRESSURE APPLYING | Division of West Coast Imports (DWCI) | |
| 10/1/2018 | 84MVVDEVICE, ACUPRESSURE | Division of Southeast Imports (DSEI) | |
| 1/29/2018 | 89KNMDEVICE, PRESSURE APPLYING | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 89KNMDEVICE, PRESSURE APPLYING | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 3/14/2017 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 5/13/2016 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 3260NO ENGLISH | Seattle District Office (SEA-DO) |
| 1/6/2016 | 84MVVDEVICE, ACUPRESSURE | 3260NO ENGLISH | Seattle District Office (SEA-DO) |
| 3/5/2014 | 89KNMDEVICE, PRESSURE APPLYING | 3081INVDEVICE | Los Angeles District Office (LOS-DO) |
| 9/10/2013 | 89KNMDEVICE, PRESSURE APPLYING | 237NO PMA | Los Angeles District Office (LOS-DO) |
| 9/10/2013 | 89KNMDEVICE, PRESSURE APPLYING | 237NO PMA | Los Angeles District Office (LOS-DO) |
| 8/6/2013 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Los Angeles District Office (LOS-DO) | |
| 3/13/2013 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 3/2/2012 | 84MVVDEVICE, ACUPRESSURE | San Francisco District Office (SAN-DO) | |
| 8/7/2009 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 3/8/2006 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Los Angeles District Office (LOS-DO) | |
| 2/7/2006 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 2/7/2006 | 80LDQDEVICE, GENERAL MEDICAL | Los Angeles District Office (LOS-DO) | |
| 2/7/2006 | 80LDQDEVICE, GENERAL MEDICAL | Los Angeles District Office (LOS-DO) | |
| 2/7/2006 | 80LDQDEVICE, GENERAL MEDICAL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hansol Medical's FDA import refusal history?
Hansol Medical (FEI: 3005417950) has 22 FDA import refusal record(s) in our database, spanning from 2/7/2006 to 2/6/2024.
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 3005417950.
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.