Nuga Medical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004006265 • Wonju, Gangwon • SOUTH KOREA
FEI Number
3004006265
Location
Wonju, Gangwon
Country
SOUTH KOREAAddress
185 Jiraeul-Ro, Jijeong-Myeon, Wonju, Gangwon, 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).
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
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.
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).
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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/29/2021 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/10/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/16/2018 | 89IRTPAD, HEATING, POWERED | 3724DEVGMPS | Division of West Coast Imports (DWCI) |
| 4/2/2018 | 89IRTPAD, HEATING, POWERED | Division of West Coast Imports (DWCI) | |
| 4/2/2018 | 77MYBPILLOW, CERVICAL (FOR MILD SLEEP APNEA) | Division of West Coast Imports (DWCI) | |
| 4/2/2018 | 89IRTPAD, HEATING, POWERED | Division of West Coast Imports (DWCI) | |
| 4/2/2018 | 89IRTPAD, HEATING, POWERED | Division of West Coast Imports (DWCI) | |
| 4/2/2018 | 89IRTPAD, HEATING, POWERED | Division of West Coast Imports (DWCI) | |
| 4/2/2018 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of West Coast Imports (DWCI) | |
| 3/31/2016 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of West Coast Imports (DWCI) | |
| 3/31/2016 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of West Coast Imports (DWCI) | |
| 2/22/2007 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 4/27/2005 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Nuga Medical Co., Ltd.'s FDA import refusal history?
Nuga Medical Co., Ltd. (FEI: 3004006265) has 13 FDA import refusal record(s) in our database, spanning from 4/27/2005 to 4/29/2021.
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. Nuga Medical Co., Ltd.'s FEI number is 3004006265.
What types of violations has Nuga Medical Co., Ltd. received?
Nuga Medical Co., Ltd. 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 Nuga Medical Co., Ltd. come from?
All FDA import refusal data for Nuga Medical Co., 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.