GUANGZHOU EKAI ELECTRONIC TECHNO
⚠️ High Risk
FEI: 3013360665 • Guangzhou, Guangdong • CHINA
FEI Number
3013360665
Location
Guangzhou, Guangdong
Country
CHINAAddress
Building A F/3, No. 81 Zijing Street, Guangzhou, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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.
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 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).
3904
3905
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 10/14/2025 | 53QY99COSMETIC PACKAGING AND LABELING, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/27/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/22/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 7/22/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 7/3/2025 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/16/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | Division of West Coast Imports (DWCI) | |
| 6/10/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 5/30/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/28/2025 | 79QQFSKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/24/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | Division of West Coast Imports (DWCI) | |
| 4/1/2025 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/11/2024 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Division of Southeast Imports (DSEI) | |
| 11/14/2024 | 79QAIPOWERED MICRONEEDLE DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/28/2024 | 79QQFSKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/14/2024 | 79QQFSKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/14/2024 | 79QQFSKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/9/2024 | 79QAIPOWERED MICRONEEDLE DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/6/2023 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/22/2023 | 79QAIPOWERED MICRONEEDLE DEVICE | Division of West Coast Imports (DWCI) | |
| 2/7/2023 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/7/2023 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 237NO PMA | Division of Southeast Imports (DSEI) |
| 6/24/2021 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 6/24/2021 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 3/1/2018 | 89KNMDEVICE, PRESSURE APPLYING | Division of Northern Border Imports (DNBI) | |
| 8/30/2017 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/9/2017 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 8/9/2017 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 7/17/2017 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is GUANGZHOU EKAI ELECTRONIC TECHNO's FDA import refusal history?
GUANGZHOU EKAI ELECTRONIC TECHNO (FEI: 3013360665) has 29 FDA import refusal record(s) in our database, spanning from 7/17/2017 to 10/21/2025.
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. GUANGZHOU EKAI ELECTRONIC TECHNO's FEI number is 3013360665.
What types of violations has GUANGZHOU EKAI ELECTRONIC TECHNO received?
GUANGZHOU EKAI ELECTRONIC TECHNO 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 GUANGZHOU EKAI ELECTRONIC TECHNO come from?
All FDA import refusal data for GUANGZHOU EKAI ELECTRONIC TECHNO 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.