Body Clock Health Care Ltd
⚠️ High Risk
FEI: 3003267895 • London • UNITED KINGDOM
FEI Number
3003267895
Location
London
Country
UNITED KINGDOMAddress
108 George Lane, SOUTH WOODFORD, London, , United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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(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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2025 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 10/7/2024 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 10/7/2024 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 11/28/2022 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/15/2021 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/1/2021 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 237NO PMA | Division of Southeast Imports (DSEI) |
| 12/15/2020 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 10/26/2020 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Division of Northern Border Imports (DNBI) | |
| 10/19/2020 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 6/30/2020 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 237NO PMA | Division of Southeast Imports (DSEI) |
| 10/18/2011 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 11/17/2006 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 2480RXPERSONAL | New Orleans District Office (NOL-DO) |
| 10/31/2006 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 2480RXPERSONAL | New Orleans District Office (NOL-DO) |
| 10/31/2006 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 10/31/2006 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 10/31/2006 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 10/31/2006 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 10/31/2006 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 10/31/2006 | 89IPFSTIMULATOR, MUSCLE, POWERED | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 10/31/2006 | 84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 8/22/2006 | 89IPFSTIMULATOR, MUSCLE, POWERED | New Orleans District Office (NOL-DO) | |
| 2/18/2002 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Body Clock Health Care Ltd's FDA import refusal history?
Body Clock Health Care Ltd (FEI: 3003267895) has 23 FDA import refusal record(s) in our database, spanning from 2/18/2002 to 11/10/2025.
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. Body Clock Health Care Ltd's FEI number is 3003267895.
What types of violations has Body Clock Health Care Ltd received?
Body Clock Health Care 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 Body Clock Health Care Ltd come from?
All FDA import refusal data for Body Clock Health Care 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.