CURRENTBODY COM LT
⚠️ Moderate Risk
FEI: 3017152879 • Cheadle Hulme • UNITED KINGDOM
FEI Number
3017152879
Location
Cheadle Hulme
Country
UNITED KINGDOMAddress
Unit D, 6 Stanley G, Cheadle Hulme, , 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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/12/2024 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/21/2022 | 78KPISTIMULATOR, ELECTRICAL FOR INCONTINENCE (NON-IMPLANTABLE) | Division of Southeast Imports (DSEI) | |
| 7/21/2022 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Division of Northern Border Imports (DNBI) | |
| 6/22/2022 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Southeast Imports (DSEI) | |
| 6/7/2022 | 85HGXPUMP, BREAST, POWERED | Division of Southeast Imports (DSEI) | |
| 5/20/2022 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | Division of Southeast Imports (DSEI) | |
| 11/8/2021 | 95RHLLASER THERAPY PRODUCT | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/28/2021 | 85OHHBREAST PUMP KIT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CURRENTBODY COM LT's FDA import refusal history?
CURRENTBODY COM LT (FEI: 3017152879) has 9 FDA import refusal record(s) in our database, spanning from 1/28/2021 to 2/12/2024.
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. CURRENTBODY COM LT's FEI number is 3017152879.
What types of violations has CURRENTBODY COM LT received?
CURRENTBODY COM LT has been cited for 6 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 CURRENTBODY COM LT come from?
All FDA import refusal data for CURRENTBODY COM LT 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.