Cleared Special

Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)

K253276 · Shanghai Bangbang Robotics Co., Ltd. · Physical Medicine

Jan 2026

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K253276 is an FDA 510(k) clearance for the Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02), 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 January 15, 2026, 108 days after receiving the submission on September 29, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3860.

Submission Details

510(k) Number	K253276 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	January 15, 2026
Days to Decision	108 days
Submission Type	Special
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).