Cleared Traditional

K041766 - EZY-TRAVEL WRISTBAND

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.

FDA 510(k) Submission Details - K041766

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

At panel average

Panel avg: 149d · This submission: 149d

Pathway characteristics

Predicate-based equivalence.

MVV Device Classification - Class 0,

Product Code	MVV Device, Acupressure
Device Class	-

Regulatory Peers - MVV Device, Acupressure

All 12

Devices cleared under the same product code (MVV) and FDA review panel - the closest regulatory comparables to K041766.

PSI BANDS

K070766 · Psi Health Solutions, Inc. · Jul 2007

ACUBAND ACUPRESSURE WRIST BAND DEVICE

K053509 · Acuband, Inc. · Aug 2006

BIOBANDS

K051397 · Biobands Distributors, Inc. · Sep 2005

ACU-STRAP MOTION SICKNESS BAND

K041877 · Health Ent., Inc. · Oct 2004

SEA-BAND

K033268 · Sea-Band UK , Ltd. · Jan 2004

ACU-BAND ACCUPRESSURE WRIST BAND

K900588 · Euro-Am Pharma, Inc. · Feb 1990

FDA 510(k) Resources - Neurology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K041766

Apothecary Products, Inc.

Burnsville, MN · US

DAVID KRAMER

Regulatory profile

6 submissions 6 cleared

100% clearance rate · Active in Neurology

View all devices by Apothecary Products, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: November 26, 2004. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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