NINGBO HESI ELECTRIC CO., LTD
⚠️ Moderate Risk
FEI: 3009784099 • Ningbo, Zhejiang • CHINA
FEI Number
3009784099
Location
Ningbo, Zhejiang
Country
CHINAAddress
156 No. 818-23 Qiming Rd, Yinzhou, 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
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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
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(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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).
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 |
|---|---|---|---|
| 4/18/2013 | 79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION | Seattle District Office (SEA-DO) | |
| 11/6/2012 | 79OYWFOR THE REMOVAL OF FAT THROUGH LASER LIPOLYSIS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is NINGBO HESI ELECTRIC CO., LTD's FDA import refusal history?
NINGBO HESI ELECTRIC CO., LTD (FEI: 3009784099) has 2 FDA import refusal record(s) in our database, spanning from 11/6/2012 to 4/18/2013.
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 HESI ELECTRIC CO., LTD's FEI number is 3009784099.
What types of violations has NINGBO HESI ELECTRIC CO., LTD received?
NINGBO HESI ELECTRIC CO., LTD has been cited for 8 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 HESI ELECTRIC CO., LTD come from?
All FDA import refusal data for NINGBO HESI ELECTRIC 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.