Cleared Traditional

Manual Wheelchair (SYIV100A008)

K252517 · Ningbo Shenyu Medical Equipment Co.,Ltd · Physical Medicine

Oct 2025

Decision

53d

Days

Class 1

Risk

About This 510(k) Submission

K252517 is an FDA 510(k) clearance for the Manual Wheelchair (SYIV100A008), a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Ningbo Shenyu Medical Equipment Co.,Ltd (Yuyao, CN). The FDA issued a Cleared decision on October 3, 2025, 53 days after receiving the submission on August 11, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K252517 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2025
Decision Date	October 03, 2025
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

Device Classification

Product Code	IOR — Wheelchair, Mechanical
Device Class	Class I — 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.