Boditech Med, Inc.
⚠️ Moderate Risk
FEI: 3009491259 • Chuncheon, Gangwon • SOUTH KOREA
FEI Number
3009491259
Location
Chuncheon, Gangwon
Country
SOUTH KOREAAddress
43 Geodudanji1-Gil, Dongnae-Myeon, Chuncheon, 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
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).
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 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).
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 |
|---|---|---|---|
| 4/7/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/12/2022 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 12/19/2021 | 75LPIKIT, ASSAY, PROGESTERONE RECEPTOR | Division of Southeast Imports (DSEI) | |
| 12/1/2021 | 75LPIKIT, ASSAY, PROGESTERONE RECEPTOR | Division of Southeast Imports (DSEI) | |
| 2/12/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/23/2019 | 75JLSRADIOIMMUNOASSAY, PROGESTERONE | Division of Southeast Imports (DSEI) | |
| 5/4/2018 | 80LDQDEVICE, GENERAL MEDICAL | Division of Southeast Imports (DSEI) | |
| 9/14/2015 | 82DCNSYSTEM, TEST, C-REACTIVE PROTEIN | 341REGISTERED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Boditech Med, Inc.'s FDA import refusal history?
Boditech Med, Inc. (FEI: 3009491259) has 8 FDA import refusal record(s) in our database, spanning from 9/14/2015 to 4/7/2022.
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. Boditech Med, Inc.'s FEI number is 3009491259.
What types of violations has Boditech Med, Inc. received?
Boditech Med, Inc. has been cited for 6 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 Boditech Med, Inc. come from?
All FDA import refusal data for Boditech Med, 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.