Electric Wheelchair (Robooter E40), Model name: BBR-E40-01
Device Facts
| Record ID | K231868 |
|---|---|
| Device Name | Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 |
| Applicant | Shanghai Bangbang Robotics Co., Ltd. |
| Product Code | ITI · Physical Medicine |
| Decision Date | Oct 31, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3860 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Battery-operated, 2-wheel rear-drive powered wheelchair; provides indoor/outdoor mobility. User operates via control panel on armrest (joystick) or smartphone app via Bluetooth 4.1 BLE. App allows remote driving, battery status viewing, speed adjustment, and device locking. Control panel input takes priority over app remote control for safety. Electromagnetic braking system engages when controller rocker is released. Device features manual folding/expansion and interchangeable joystick side. Used by patients in various environments; assists mobility for those with limited physical capacity.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including performance, EMC, wireless coexistence, and biocompatibility testing per ISO 7176, ANSI C63.27, and ISO 10993 standards.
Technological Characteristics
24V DC 20Ah lithium-ion battery; 2-wheel rear-drive; electromagnetic braking; Bluetooth 4.1 BLE connectivity. Materials evaluated for biocompatibility per ISO 10993-5, -10, -23. Conforms to ISO 7176 series for stability, braking, energy consumption, dimensions, and EMC.
Indications for Use
Indicated for persons limited to a seated position capable of operating a powered wheelchair, for indoor and outdoor mobility.
Regulatory Classification
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.
Predicate Devices
- Electric Wheelchair (K223393)
Submission Summary (Full Text)
{0}------------------------------------------------
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"
{1}------------------------------------------------
(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
{2}------------------------------------------------
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
## 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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
## 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<br>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 |
{5}------------------------------------------------
#### 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
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.
### 6. Compared to Predicate Device
Compared to the predicate device, the subject device has the same intended use, similar product design, and similar performance. The summarized comparison is listed in the following table:
| SE<br>Comparisons | Subject Device<br>Electric Wheelchair (Robooter<br>E40)<br>(Model: BBR-E40-01) | Predicate Device<br>Electric Wheelchair<br>(Model: BBR-LY-01-01) | Similarities/<br>Differences |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 510(K) number | K231868 | K223393 | / |
| Indication for<br>Use | The intended use of the<br>Electric Wheelchair (Robooter<br>E40), Model name: BBR-E40-<br>01 is to provide outdoor and<br>indoor mobility to persons | The intended use of the Electric<br>Wheelchair (Model: BBR-LY-01-<br>01) is to provide outdoor and<br>indoor mobility to persons limited<br>to a seated position that are | Same |
| | limited to a seated position<br>that are capable of operating<br>a powered wheelchair. | capable of operating a powered<br>wheelchair. | |
| Product code | ITI | ITI | Same |
| Class | II | II | Same |
| Regulation<br>Number | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Common name | Wheelchair, Powered | Wheelchair, Powered | Same |
| Type of Use | Over the Counter (OTC Only) | Over the Counter (OTC Only) | Same |
| Device Length | 1000 mm | 1075 mm | Different See<br>Note 1 |
| Device Width | 624mm | 628 mm | Different See<br>Note 1 |
| Device Height | 930mm | 930 mm | Same |
| Stowage Length | 700mm | 895 mm | Different See<br>Note 1 |
| Stowage Width | 624mm | 628 mm | Different See<br>Note 1 |
| Stowage Height | 450mm | 395 mm | Different See<br>Note 1 |
| Number of<br>wheels | 4 | 4 | Same |
| Front Wheel<br>Diameter | 8 in | 10 in | Different See<br>Note 2 |
| Rear Wheel<br>Diameter | 10 in | 10 in | Same |
| Battery pack | 1 rechargeable lithium-ion<br>battery<br>Ratings: 24 V 20Ah | 1 rechargeable lithium-ion<br>battery<br>Ratings: 24 V 20Ah | Same |
| Battery weight | 3.4kg | 3.4kg | Same |
| Charger | Input: 100-240V AC<br>50/60Hz 2.2A<br>Output: 29.4V DC 3A | Input: 100-<br>240VAC 50-60Hz<br>1.9A<br>Output: 24V DC 4A | Different See<br>Note 3 |
| Maximum<br>Weight Capacity | 150kg | 120kg | Different See<br>Note 4 |
| Maximum<br>forward speed<br>(maximum safe<br>speed) | 7.1km/h | 6km/h | Different See<br>Note 5 |
| Speed Settings | 5 | 5 | Same |
| Braking System | Electromagnetic | Electromagnetic | Same |
| Braking<br>mechanism in<br>case of electrical<br>Brake Failure | Normally closed brakes be<br>employed. When<br>the device is powered off or<br>when electrical power<br>is lost, the brakes engaged on | Normally closed brakes be<br>employed. When<br>the device is powered off or<br>when electrical power<br>is lost, the brakes engaged on | Same |
| | the motors to prevent rotation. | the motors to prevent rotation. | |
| Minimum braking<br>distance from<br>max<br>Speed | 102cm | 120cm | Different See<br>Note 6 |
| Turning Radius | 450mm | 380 mm | Different See<br>Note 1 |
| Obstacle<br>Climbing Height | 40mm | 45mm | Different See<br>Note 1 |
| Ground<br>clearance | 65 mm | 64 mm | Similar. See Note<br>1. |
| Drive system | 2 Wheel Drive (Rear wheel<br>drive) | 2 Wheel Drive (Rear wheel drive) | Same |
| Folding<br>mechanism | Manually fold/expand | Automatically fold/ expand drove<br>by motor | Different See<br>Note 7 |
| Dynamic Stability | 9° | 6° | Different See<br>Note 8 |
| Driving Range<br>(full<br>battery charge)/<br>Maximum<br>distance<br>on fully battery<br>charge | 21.5km | 20.6km | Different See<br>Note 4 |
| On/Off Button | Yes, Power Button on the<br>control pad | Yes, Power Button on the<br>control pad | Same |
| rocker Location | Right/left can be interchange | Right arm | Different<br>The location<br>of rocker<br>does not<br>affect safety<br>and<br>effectiveness |
| Seat Widths | 420mm | 425mm | Different<br>See Note 2 |
| Seat Depths | 430mm | 425mm | Different<br>See Note 2 |
| Back support<br>Height | 460mm | 455mm | Different<br>See Note 2 |
| Operating<br>Conditions | -10°C~50°C | -10°C~50°C | Same |
| Storage<br>Conditions | -20 °C~60 °C | -40 °C~60 °C | Different<br>See Note 9 |
| Smartphone<br>App | iOS and Android | iOS and Android | Same |
| Wireless RF<br>frequency<br>range | 2.400GHz ~ 2.4835GHz | 2.400GHz ~ 2.4835GHz | Same |
| Wireless RF<br>maximum<br>output<br>power | +4dBm~-20dBm (in 4dB steps) | +4dBm~-20dBm (in 4dB steps) | Same |
| Wireless<br>operating<br>range | 10m | 10m | Same |
| Non clinical testing | | | |
| Performance | wheelchair conforms to the<br>ISO 7176 standards | wheelchair conforms to the ISO<br>7176 standards | Same |
| Flammability<br>Testing | wheelchair conforms to the<br>ISO 7176-16 standards | wheelchair conforms to the ISO<br>7176-16 standards | Same |
| Biocompatibility | wheelchair conforms to ISO<br>10993-5:2009,ISO 10993-<br>10:201 and ISO 10993-<br>23:2021 | wheelchair conforms to ISO<br>10993-5:2009 and ISO 10993-<br>10:2010 | Different<br>See Note 10 |
| EMC | wheelchair conforms to ISO<br>7176-21:2009 | wheelchair conforms to ISO<br>7176-21:2009 | Same |
| Wireless | wheelchair conforms to ANSI<br>C63.27-2017 | wheelchair conforms to ANSI<br>C63.27-2017 | |
| coexistence | | | Same |
510(k) Summary
{6}------------------------------------------------
510(k) Summary
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
Note 1: The predicate device and subject device have different dimensions. Both comply with ISO 7176-5:2008 Wheelchairs – Part 5: Determination of dimensions, mass, and maneuverings space so these differences do not affect safety and effectiveness.
Note 2: Both the subject device and the predicate device comply with ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions, so these differences do not affect safety and effectiveness.
Note 3: The battery charger of both the subject device and predicate device complies with ISO 7176-25: 2013 Wheelchairs – Part 25: Batteries and chargers for powered wheelchairs, so these differences do not affect safety and effectiveness.
Note 4: Both the subject device and the predicate device comply with ISO 7176-4: 2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range, so these differences do not affect safety and effectiveness.
Note 5: Both the subject device and the predicate device comply with ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs, so these differences does not affect safety and effectiveness.
Note 6: Both the subject device and the predicate device comply with ISO 7176-3:2017 Wheelchairs - Part 3: Determination of effectiveness of brakes, so this difference does not affect safety and effectiveness.
Note 7: The subject device can be folded/expanded manually, the folding mechanism can bear the specified mass in the intended environment, and it does not cause mechanic or other hazards, so this difference does not affect safety and effectiveness.
Note 8: Both the subject device and the predicate device comply with ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs, so the noted difference does not affect safety and effectiveness.
Note 9: Both the subject device and the predicate device comply with ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs. These differences do not affect safety and effectiveness.
{10}------------------------------------------------
Note 10: Both the subject device and the predicate device evaluated biocompatibility according to ISO 10993 series standards. Although the standard version updated, test methods for the subject device and the predicate device are same.
The subject device and predicate device are substantially equivalent in the areas of technological characteristics such as basic design, features, energy source, method of operation, general function, application, and intended use. The subject device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
#### 8. Performance Testing Summary
#### The subject device Electric Wheelchair (Model: BBR-E40-01) comply with:
#### 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
{11}------------------------------------------------
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
#### 9. Conclusion
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.
