Cleared Traditional

ICON 35 (K260849) - FDA 510(k) Clearance

Also marketed or referenced as:
ICON 45 ICON 60 ICON 30FAF

Class I Physical Medicine device.

K260849 · Rehasense USA, Inc. · Physical Medicine device
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Jun 2026
Decision
87d
Days
Class 1
Risk

K260849 is an FDA 510(k) clearance for the ICON 35. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Rehasense USA, Inc. (Romeoville, US). The FDA issued a Cleared decision on June 11, 2026 after a review of 87 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 Rehasense USA, Inc. devices

Submission Details

510(k) Number K260849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2026
Decision Date June 11, 2026
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 77
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K260849.
Manual Wheelchair (LW01108)
K260642 · Anhui Longway Medical Technology Co., Ltd. · Jun 2026
Helio Kids
K260295 · Motion Composites · May 2026
Manual Wheelchair (DY01903(2))
K254141 · Guangdong Dayang Medical Technology Co., Ltd. · May 2026
Manual Wheelchair (7101L, 7102LHD)
K260121 · Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · Apr 2026
Manual Wheelchair (W50)
K253632 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Jan 2026
EmpowerRide NAVIGATOR
K251886 · Empower Ride, LLC · Jan 2026