Cleared Traditional

Power wheelchair (Model:BC-EA8000)

K232121 · Ningbo Baichen Medical Devices Co., Ltd. · Physical Medicine

Sep 2023

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K232121 is an FDA 510(k) clearance for the Power wheelchair (Model:BC-EA8000), a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Ningbo Baichen Medical Devices Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on September 15, 2023, 60 days after receiving the submission on July 17, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K232121 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 2023
Decision Date	September 15, 2023
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	ITI — Wheelchair, Powered
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.3860
Definition	A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).