Cleared Traditional

K102837 - HIROLLER ELEVATING WHEELCHAIR

K102837 is an FDA 510(k) clearance for HIROLLER ELEVATING WHEELCHAIR, manufactured by Max Mobility, LLC. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K102837 · Max Mobility, LLC · Physical Medicine device
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Dec 2010
Decision
85d
Days
Class 2
Risk

K102837 is an FDA 510(k) clearance for the HIROLLER ELEVATING WHEELCHAIR. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Max Mobility, LLC (Antioch, US). The FDA issued a Cleared decision on December 23, 2010 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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 Max Mobility, LLC devices

FDA 510(k) Submission Details - K102837

510(k) Number K102837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date December 23, 2010
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPL Device Classification - Class 2, Special Controls

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
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 - IPL Wheelchair, Standup

All 12
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K102837.
Modular Power Standing System
K191376 · Motion Concepts · Aug 2019
Quickie(r) Q700-UP M
K172384 · Sunrise Medical (Us), LLC · Jan 2018
Action Trackstander models TR1816, TR1820, TR2016, and TR2020
K163451 · Action Manufacturing, Inc. · Jan 2018
RISER STANDUP WHEELCHAIR
K832696 · Imex Medical Systems, Inc. · Sep 1983
LEVO-STAND-UP WHEELCHAIR
K790265 · Marion Laboratories, Inc. · Feb 1979