Cleared Traditional

K252370 - GEN 4 JOY Wheelchair

K252370 is an FDA 510(k) clearance for GEN 4 JOY Wheelchair, manufactured by Free Wheelchair Mission. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K252370 · Free Wheelchair Mission · Physical Medicine device
Download Printable Device Report (PDF)
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Jul 2026
Decision
359d
Days
Class 1
Risk

K252370 is an FDA 510(k) clearance for the GEN 4 JOY Wheelchair. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Free Wheelchair Mission (Irvine, US). The FDA issued a Cleared decision on July 24, 2026 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Free Wheelchair Mission devices

FDA 510(k) Submission Details - K252370

510(k) Number K252370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2025
Decision Date July 24, 2026
Days to Decision 359 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
244d slower than avg
Panel avg: 115d · This submission: 359d
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 220
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K252370.
Manual Wheelchair (H008, PCK7)
K261571 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Aug 2026
Manual Wheelchair (MS01)
K261075 · GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. · Jun 2026
Caregiver-assisted wheelchair (MS02)
K261076 · GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. · Jun 2026
ICON 35
K260849 · Rehasense USA, Inc. · Jun 2026
Manual Wheelchair (LW01108)
K260642 · Anhui Longway Medical Technology Co., Ltd. · Jun 2026
Helio Kids
K260295 · Motion Composites · May 2026