XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED
⚠️ Moderate Risk
FEI: 3012184077 • Xiamen, Fujian • CHINA
FEI Number
3012184077
Location
Xiamen, Fujian
Country
CHINAAddress
Building D Floor 2-3, NO. 100 Jinfu Road; Tongan District, Xiamen, Fujian, China
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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2023 | 89IRPMASSAGER, POWERED INFLATABLE TUBE | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 7/6/2022 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 237NO PMA | Division of Northeast Imports (DNEI) |
| 2/17/2022 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 2/7/2022 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 1/10/2022 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED's FDA import refusal history?
XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED (FEI: 3012184077) has 5 FDA import refusal record(s) in our database, spanning from 1/10/2022 to 10/17/2023.
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. XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED's FEI number is 3012184077.
What types of violations has XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED received?
XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED has been cited for 2 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 XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED come from?
All FDA import refusal data for XIAMEN EMOKA HEALTH SCIENCE AND TECHNOLOGY COMPANY LIMITED 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.