Cleared Traditional

K933406 - TRAVEL EASE

K933406 is an FDA 510(k) clearance for TRAVEL EASE, manufactured by Merits Health Products., Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K933406 · Merits Health Products., Inc. · Physical Medicine device
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Sep 1993
Decision
80d
Days
Class 1
Risk

K933406 is an FDA 510(k) clearance for the TRAVEL EASE. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Merits Health Products., Inc. (Cape Coral, US). The FDA issued a Cleared decision on September 30, 1993 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - the FDA physical medicine device framework. 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 Merits Health Products., Inc. devices

FDA 510(k) Submission Details - K933406

510(k) Number K933406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1993
Decision Date September 30, 1993
Days to Decision 80 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 93
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K933406.
RECORD
K940303 · Everest & Jennings, Inc. · Feb 1994
NITRO
K940304 · Everest & Jennings, Inc. · Feb 1994
ACTION WIZARD PEDIATRIC MANUAL WHEELCHAIR
K934646 · Invacare Corp. · Dec 1993
UNIVERSAL WHEELCHAIR
K930411 · Everest & Jennings, Inc. · Mar 1993
PREMIER 2 WHEELCHAIR
K930412 · Everest & Jennings, Inc. · Mar 1993
PREMIER CLASSIC
K930413 · Everest & Jennings, Inc. · Mar 1993