Tenscare Ltd
⚠️ Moderate Risk
FEI: 3006149008 • Epsom, Surrey • UNITED KINGDOM
FEI Number
3006149008
Location
Epsom, Surrey
Country
UNITED KINGDOMAddress
9 Blenheim Road, , Epsom, Surrey, United Kingdom
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 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.
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/7/2022 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/25/2022 | 84OBPTRANSCRANIAL MAGNETIC STIMULATOR | Division of Southeast Imports (DSEI) | |
| 11/4/2020 | 84NHINERVE, STIMULATOR, ELECTRICAL, PERCUTANEOUS (PENS) FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 5/29/2012 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Tenscare Ltd's FDA import refusal history?
Tenscare Ltd (FEI: 3006149008) has 4 FDA import refusal record(s) in our database, spanning from 5/29/2012 to 4/7/2022.
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. Tenscare Ltd's FEI number is 3006149008.
What types of violations has Tenscare Ltd received?
Tenscare Ltd 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 Tenscare Ltd come from?
All FDA import refusal data for Tenscare 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.