Zhejiang Innuovo Rehabilitation Devices Co. Ltd.
⚠️ Moderate Risk
FEI: 3012521614 • Jinhua, Zhejiang • CHINA
FEI Number
3012521614
Location
Jinhua, Zhejiang
Country
CHINAAddress
No. 196 Industry Road, Hengdianzhen Dongyang, Jinhua, Zhejiang, 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
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 |
|---|---|---|---|
| 4/2/2024 | 89ITIWHEELCHAIR, POWERED | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 5/21/2018 | 89IORWHEELCHAIR, MECHANICAL | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 5/21/2018 | 89IORWHEELCHAIR, MECHANICAL | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 5/21/2018 | 89IORWHEELCHAIR, MECHANICAL | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Zhejiang Innuovo Rehabilitation Devices Co. Ltd.'s FDA import refusal history?
Zhejiang Innuovo Rehabilitation Devices Co. Ltd. (FEI: 3012521614) has 4 FDA import refusal record(s) in our database, spanning from 5/21/2018 to 4/2/2024.
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. Zhejiang Innuovo Rehabilitation Devices Co. Ltd.'s FEI number is 3012521614.
What types of violations has Zhejiang Innuovo Rehabilitation Devices Co. Ltd. received?
Zhejiang Innuovo Rehabilitation Devices Co. Ltd. has been cited for 1 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 Zhejiang Innuovo Rehabilitation Devices Co. Ltd. come from?
All FDA import refusal data for Zhejiang Innuovo Rehabilitation Devices 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.