Cleared Traditional

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01

K231868 · Shanghai Bangbang Robotics Co., Ltd. · Physical Medicine

Oct 2023

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K231868 is an FDA 510(k) clearance for the Electric Wheelchair (Robooter E40), Model name: BBR-E40-01, a Wheelchair, Powered (Class II — Special Controls, product code ITI), submitted by Shanghai Bangbang Robotics Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 31, 2023, 127 days after receiving the submission on June 26, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K231868 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2023
Decision Date	October 31, 2023
Days to Decision	127 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).