Cleared Traditional

K231868 - Electric Wheelchair (Robooter E40)

K231868 is an FDA 510(k) clearance for Electric Wheelchair (Robooter E40), manufactured by Shanghai Bangbang Robotics Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K231868 · Shanghai Bangbang Robotics Co., Ltd. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Oct 2023
Decision
127d
Days
Class 2
Risk

K231868 is an FDA 510(k) clearance for the Electric Wheelchair (Robooter E40), Model name: BBR-E40-01. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Shanghai Bangbang Robotics Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 31, 2023 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Shanghai Bangbang Robotics Co., Ltd. devices

FDA 510(k) Submission Details - K231868

510(k) Number K231868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 220
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K231868.
Velox Power Chair
K231315 · Velox Manufacturing, Inc. · Jan 2024
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Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)
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K232121 · Ningbo Baichen Medical Devices Co., Ltd. · Sep 2023
Ki Power Tilt System
K201869 · Ki Mobility, LLC · Sep 2023