Ningbo Ruipu Medical Comfort Equipm
⚠️ Moderate Risk
FEI: 3008634700 • Ningbo, Zhejiang • CHINA
FEI Number
3008634700
Location
Ningbo, Zhejiang
Country
CHINAAddress
No. 8 Gulin, Haishu District, Ningbo, 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
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/7/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Seattle District Office (SEA-DO) | |
| 8/31/2011 | 89IMIDIATHERMY, ULTRASONIC, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Ningbo Ruipu Medical Comfort Equipm's FDA import refusal history?
Ningbo Ruipu Medical Comfort Equipm (FEI: 3008634700) has 2 FDA import refusal record(s) in our database, spanning from 8/31/2011 to 12/7/2012.
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. Ningbo Ruipu Medical Comfort Equipm's FEI number is 3008634700.
What types of violations has Ningbo Ruipu Medical Comfort Equipm received?
Ningbo Ruipu Medical Comfort Equipm has been cited for 4 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 Ningbo Ruipu Medical Comfort Equipm come from?
All FDA import refusal data for Ningbo Ruipu Medical Comfort Equipm 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.