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Sea-Band Ltd

⚠️ Moderate Risk

FEI: 3007208023 • Leicestershire • UNITED KINGDOM

FEI

FEI Number

3007208023

📍

Location

Leicestershire

🇬🇧
🏢

Address

Lancaster Road, , Leicestershire, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

36.4
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
3
Unique Violations
8/14/2013
Latest Refusal
8/14/2013
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

163×

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.

2233×

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.

5083×

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.

Refusal History

DateProductViolationsDivision
8/14/2013
84MWTTHERAPEUTIC NEUROLOGY DEVICE, MAGNET
16DIRECTIONS
223FALSE
508NO 510(K)
Chicago District Office (CHI-DO)
8/14/2013
84MWTTHERAPEUTIC NEUROLOGY DEVICE, MAGNET
16DIRECTIONS
223FALSE
508NO 510(K)
Chicago District Office (CHI-DO)
8/14/2013
84MVVDEVICE, ACUPRESSURE
16DIRECTIONS
223FALSE
508NO 510(K)
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Sea-Band Ltd's FDA import refusal history?

Sea-Band Ltd (FEI: 3007208023) has 3 FDA import refusal record(s) in our database, spanning from 8/14/2013 to 8/14/2013.

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. Sea-Band Ltd's FEI number is 3007208023.

What types of violations has Sea-Band Ltd received?

Sea-Band Ltd has been cited for 3 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 Sea-Band Ltd come from?

All FDA import refusal data for Sea-Band 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.