Predicate Devices

الك223393

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details standard powered wheelchair components and control mechanisms (joystick, remote control via app) without mentioning any AI or ML functionalities for navigation, obstacle detection, or other advanced features. The "Mentions AI, DNN, or ML" field is also marked as "Not Found".

Therapeutic

No

The device is an electric wheelchair designed for mobility, not for treating or diagnosing a medical condition.

Diagnostic

No

The device is described as an "Electric Wheelchair" intended for mobility, not for diagnosis of any medical condition. Its function is to provide transportation, not to detect, monitor, or analyze health parameters.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including a seat system, control system, braking system, drive system, battery, motors, and the physical wheelchair structure itself. While it includes a smartphone app for remote control, this app is a component of a larger hardware device, not a standalone software-only medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The description clearly states the device is an "Electric Wheelchair" intended to provide "outdoor and indoor mobility to persons limited to a seated position." Its function is to assist with physical movement, not to analyze biological samples.
Lack of Diagnostic Testing: There is no mention of any components or processes related to collecting, analyzing, or interpreting biological samples for diagnostic purposes.
Focus on Mobility and Safety: The description focuses on the mechanical, electrical, and control systems related to operating a wheelchair for mobility, as well as safety standards and performance testing related to its function as a mobility device.

The information provided aligns with the description of a medical device used for physical assistance and mobility, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of the Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Product codes (comma separated list FDA assigned to the subject device)

ITI

Device Description

The Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is an indoor/outdoor, battery-operated, 2-wheel drive (rear-wheel drive) powered wheelchair.

It consists of four modules: seat system, control system, braking system, and drive system.

The user sits in the wheelchair seat and uses the control system.

The control panel positioned on the right or left armrest allows the user to turn the wheelchair on, control the speed, and direct the movement.

The braking system employs an electromagnetic brake. When the controller rocker is released, the electromagnetic brakes will be actuated, and the electric wheelchair will stop in several seconds. The electromagnetic brake will not take effect immediately, it will take effect after the wheel rotates for 1/2 cycle.

The wheelchair is powered by a 24V DC, 20Ah rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger. The wheelchair is driven by two DC motors.

The Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 contains Bluetooth 4.1 BLE technology. The device can be controller rocker or remote control by a smartphone app via Bluetooth 4.1 Low Energy (BLE) wireless communication interface. The smartphone app is used to drive the chair remotely. For safety, control is priority over the remote control by design. The smartphone app can also view the battery's status, adjust the speed gear level and lock/unlock the unattended device.

The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical test: Clinical testing is not required.
Non-clinical data:
Safety and performance:
ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strenaths
ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies
ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices
ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs

EMC:
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers

Wireless Co-existence:
ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence

Biocompatibility:
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization
ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests for Irritation

Key results: The conclusions drawn from the nonclinical tests demonstrate that the subject device Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is as safe, as effective, and performs as well as the legally marketed predicated device Electric Wheelchair (Model: BBR-LY-01-01) K223393.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K223393

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. 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.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 31, 2023

Shanghai BangBang Robotics Co., Ltd. Liu Canfeng Test and Certification Manager Room 501, Building 3, No.188 Zhongchen Road Songjiang District Shanghai. 201613 China

Re: K231868

Trade/Device Name: Electric Wheelchair (Robooter E40), Model: BBR-E40-01 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: October 2, 2023 Received: October 2, 2023

Dear Liu Canfeng:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231868

Device Name

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

Indications for Use (Describe)

The intended use of the Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

K231868

Prepared Date: Sep. 28,2023

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	Shanghai BangBang Robotics Co., Ltd.
Address:	Room 501, Building 3, No.188 Zhongchen Road, Songjiang
District, Shanghai 201613 China
Contact person:	Canfeng liu
Title:	Test and Certification Manager
E-mail:	liucf@bangbangrobotics.com
Tel:	86-13524910052

2. Device Identification

510(K) number:	K231868
Trade/Device Name:	Electric Wheelchair (Robooter E40)
Model:	BBR-E40-01
Common name:	Wheelchair, Powered
Regulation Number:	890.3860
Regulation Name:	Powered wheelchair
Regulation Class:	Class 2
Panel:	Physical Medicine
Product Code:	ITI

3. Predicate Device

510(K) number:	K223393
Trade/Device Name:	Electric Wheelchair
Model:	BBR-LY-01-01
Common name:	Wheelchair, Powered
Regulation Number:	890.3860
Regulation Name:	Powered wheelchair
Regulation Class:	Class 2
Panel:	Physical Medicine
Product Code:	ITI

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4. Indication for Use

The intended use of the Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

5. Device Description