Cleared Traditional

Manual Wheelchair (A006)

K231110 · Ningbo Shenyu Medical Equipment Co.,Ltd · Physical Medicine

Jun 2023

Decision

58d

Days

Class 1

Risk

About This 510(k) Submission

K231110 is an FDA 510(k) clearance for the Manual Wheelchair (A006), 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 June 16, 2023, 58 days after receiving the submission on April 19, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K231110 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2023
Decision Date	June 16, 2023
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

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.