Cleared Traditional

K041766 - EZY-TRAVEL WRISTBAND (FDA 510(k) Clearance)

K041766 · Apothecary Products, Inc. · Neurology device
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Nov 2004
Decision
149d
Days
-
Risk

K041766 is an FDA 510(k) clearance for the EZY-TRAVEL WRISTBAND. Classified as Device, Acupressure (product code MVV).

Submitted by Apothecary Products, Inc. (Burnsville, US). The FDA issued a Cleared decision on November 26, 2004 after a review of 149 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.

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Submission Details

510(k) Number K041766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2004
Decision Date November 26, 2004
Days to Decision 149 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 148d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVV Device, Acupressure
Device Class -