Cleared Traditional

ACU-STRAP MOTION SICKNESS BAND (K041877) - FDA 510(k) Clearance

K041877 · Health Ent., Inc. · Neurology device
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Oct 2004
Decision
88d
Days
-
Risk

K041877 is an FDA 510(k) clearance for the ACU-STRAP MOTION SICKNESS BAND. Classified as Device, Acupressure (product code MVV).

Submitted by Health Ent., Inc. (North Attleboro, US). The FDA issued a Cleared decision on October 8, 2004 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Health Ent., Inc. devices

Submission Details

510(k) Number K041877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2004
Decision Date October 08, 2004
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVV Device, Acupressure
Device Class -