Shen Zhen As Tec Technology Co Ltd
⚠️ High Risk
FEI: 3008689723 • Shenzhen, Guangdong • CHINA
FEI Number
3008689723
Location
Shenzhen, Guangdong
Country
CHINAAddress
808 XinBaoYi Industrial Bld, Houting Village, Beiting Road, Shajing, Shenzhen, 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).
3904
3905
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/12/2025 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | Division of West Coast Imports (DWCI) | |
| 7/11/2025 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | Division of West Coast Imports (DWCI) | |
| 2/4/2025 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 1/28/2025 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of West Coast Imports (DWCI) | |
| 12/31/2024 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 12/21/2024 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of West Coast Imports (DWCI) | |
| 12/21/2024 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of West Coast Imports (DWCI) | |
| 12/21/2024 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of West Coast Imports (DWCI) | |
| 12/3/2024 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | Division of West Coast Imports (DWCI) | |
| 11/29/2024 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of West Coast Imports (DWCI) | |
| 11/25/2024 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | Division of West Coast Imports (DWCI) | |
| 11/25/2024 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | Division of West Coast Imports (DWCI) | |
| 11/21/2024 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of West Coast Imports (DWCI) | |
| 11/21/2024 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 11/15/2024 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 11/12/2024 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | 39053905 | Division of Northern Border Imports (DNBI) |
| 11/7/2024 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of West Coast Imports (DWCI) | |
| 11/7/2024 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of West Coast Imports (DWCI) | |
| 10/11/2024 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of West Coast Imports (DWCI) | |
| 10/11/2024 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of West Coast Imports (DWCI) | |
| 9/19/2024 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of West Coast Imports (DWCI) | |
| 8/13/2024 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | Division of West Coast Imports (DWCI) | |
| 5/4/2021 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of West Coast Imports (DWCI) | |
| 12/8/2020 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 6/17/2020 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 2/19/2020 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | Division of Northern Border Imports (DNBI) | |
| 9/30/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 12/15/2016 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of Northern Border Imports (DNBI) | |
| 7/26/2016 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 5/20/2016 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | Division of Southwest Imports (DSWI) | |
| 5/20/2016 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | Division of Southwest Imports (DSWI) | |
| 5/5/2016 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | New Orleans District Office (NOL-DO) | |
| 5/5/2016 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | New Orleans District Office (NOL-DO) | |
| 5/14/2013 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shen Zhen As Tec Technology Co Ltd's FDA import refusal history?
Shen Zhen As Tec Technology Co Ltd (FEI: 3008689723) has 34 FDA import refusal record(s) in our database, spanning from 5/14/2013 to 8/12/2025.
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. Shen Zhen As Tec Technology Co Ltd's FEI number is 3008689723.
What types of violations has Shen Zhen As Tec Technology Co Ltd received?
Shen Zhen As Tec Technology 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 Shen Zhen As Tec Technology Co Ltd come from?
All FDA import refusal data for Shen Zhen As Tec Technology 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.