Cleared Traditional

K040097 - MEDLINE STRIDER MIDI 3

K040097 is the FDA 510(k) clearance for MEDLINE STRIDER MIDI 3 by Medline Industries, Inc.. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K040097 · Medline Industries, Inc. · Physical Medicine device
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Feb 2004
Decision
24d
Days
Class 2
Risk

K040097 is an FDA 510(k) clearance for the MEDLINE STRIDER MIDI 3. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 13, 2004 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K040097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date February 13, 2004
Days to Decision 24 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INI Vehicle, Motorized 3-wheeled

All 79
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K040097.
MEDLINE STRIDER MAXI 4
K041055 · Medline Industries, Inc. · May 2004
MEDLINE STRIDER MINI 3
K040818 · Medline Industries, Inc. · May 2004
MEDLINE STRIDER MINI 4
K040838 · Medline Industries, Inc. · May 2004
MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4
K032446 · Medline Industries, Inc. · Feb 2004
INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
K030814 · Invacare Corp. · Mar 2003
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
K010135 · Invacare Corp. · Feb 2001