Cleared Traditional

K261571 - Manual Wheelchair (H008, PCK7)

K261571 is an FDA 510(k) clearance for Manual Wheelchair (H008, manufactured by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K261571 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
86d
Days
Class 1
Risk

K261571 is an FDA 510(k) clearance for the Manual Wheelchair (H008, PCK7). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang Jiangsu, CN). The FDA issued a Cleared decision on August 6, 2026 after a review of 86 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.

FDA 510(k) Submission Details - K261571

510(k) Number K261571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2026
Decision Date August 06, 2026
Days to Decision 86 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
30d faster than avg
Panel avg: 116d · This submission: 86d
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 466
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K261571.
Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)
K260141 · Zhenjiang Assure Medical Equipment Co., Ltd. · Sep 2026
Reclining wheelchair (YJ-013L)
K260144 · Zhenjiang Assure Medical Equipment Co., Ltd. · Sep 2026
YJ-K1K2 Wheelchair (YJ-013F)
K260145 · Zhenjiang Assure Medical Equipment Co., Ltd. · Sep 2026
GEN 4 JOY Wheelchair
K252370 · Free Wheelchair Mission · Jul 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
K261571 · Manual Wheelchair (H008, PCK7)
Download PDF FDA Summary Jiangsu Yuyue Medical…