Cleared Traditional

Manual Wheelchair, Model A011

K201461 · Ningbo Shenyu Medical Equipment Co.,Ltd · Physical Medicine

May 2021

Decision

353d

Days

Class 1

Risk

About This 510(k) Submission

K201461 is an FDA 510(k) clearance for the Manual Wheelchair, Model A011, 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 May 21, 2021, 353 days after receiving the submission on June 2, 2020. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K201461 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2020
Decision Date	May 21, 2021
Days to Decision	353 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.