Cleared Traditional

K041055 - MEDLINE STRIDER MAXI 4

K041055 is the FDA 510(k) clearance for MEDLINE STRIDER MAXI 4 by Medline Industries, Inc.. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K041055 · Medline Industries, Inc. · Physical Medicine device
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May 2004
Decision
32d
Days
Class 2
Risk

K041055 is an FDA 510(k) clearance for the MEDLINE STRIDER MAXI 4. 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 May 25, 2004 after a review of 32 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 K041055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2004
Decision Date May 25, 2004
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
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 K041055.
MODIFICATION TO MEDLINE STRIDER MIDI 3
K042763 · Medline Industries, Inc. · Oct 2004
MEDLINE STRIDER MICRO 3
K041053 · Medline Industries, Inc. · May 2004
MEDLINE STRIDER MAXI 3
K041054 · 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 MIDI 3
K040097 · Medline Industries, Inc. · Feb 2004