Cleared Traditional

Caregiver-assisted wheelchair (MS02) (K261076) - FDA 510(k) Clearance

Also marketed or referenced as:
Caregiver-assisted wheelchair (MA02)

Class I Physical Medicine device.

K261076 · GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
82d
Days
Class 1
Risk

K261076 is an FDA 510(k) clearance for the Caregiver-assisted wheelchair (MS02). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on June 22, 2026 after a review of 82 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 GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. devices

Submission Details

510(k) Number K261076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2026
Decision Date June 22, 2026
Days to Decision 82 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 115d · This submission: 82d
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 K261076.
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