Cleared Traditional

SEA-BAND (K033268) - FDA 510(k) Clearance

K033268 · Sea-Band UK , Ltd. · Neurology device
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Jan 2004
Decision
90d
Days
-
Risk

K033268 is an FDA 510(k) clearance for the SEA-BAND. Classified as Device, Acupressure (product code MVV).

Submitted by Sea-Band UK , Ltd. (Stevenage, Herts., GB). The FDA issued a Cleared decision on January 7, 2004 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sea-Band UK , Ltd. devices

Submission Details

510(k) Number K033268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2003
Decision Date January 07, 2004
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVV Device, Acupressure
Device Class -