Electric Wheelchair

K223393 · Shanghai Bangbang Robotics Co., Ltd. · ITI · Mar 16, 2023 · Physical Medicine

Device Facts

• Record ID: K223393
• Device Name: Electric Wheelchair
• Applicant: Shanghai Bangbang Robotics Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Mar 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Electric Wheelchair (Model: BBR-LY-01-01) 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 drive powered wheelchair; provides indoor/outdoor mobility. User operates via control pad on right armrest or smartphone app via Bluetooth 4.1 BLE. Controller rocker input takes priority over remote app control for safety. Electromagnetic braking system engages upon rocker release (after 1/2 wheel rotation). Features automatic folding mechanism. Powered by 24V DC lithium-ion battery. Intended for use by individuals with limited mobility; provides mobility assistance and independence. Smartphone app allows remote driving, battery status monitoring, speed gear adjustment, and device locking/unlocking.

Clinical Evidence

No clinical data. Bench testing only. Device performance verified against ISO 7176 series (stability, braking, energy consumption, dimensions, speed, fatigue, climatic, obstacle climbing), EMC (ISO 7176-21, IEC 60601-1-2), wireless coexistence (ANSI C63.27), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

2-wheel rear-drive powered wheelchair; 24V DC 20Ah lithium-ion battery; electromagnetic braking; Bluetooth 4.1 BLE connectivity. Automatic folding mechanism. Conforms to ISO 7176 series for performance, ISO 10993 for biocompatibility, and ISO 7176-21/IEC 60601-1-2 for EMC. Wireless operation via smartphone app.

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

• WHILL Model C2 (K213383)

Submission Summary (Full Text)

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March 15, 2023

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

Re: K223393

Trade/Device Name: Electric Wheelchair (Model: BBR-LY-01-01) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 29, 2023 Received: February 2, 2023

Dear Canfeng Liu:

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 (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 located 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K223393

Device Name Electric Wheelchair (Model: BBR-LY-01-01)

Indications for Use (Describe)

The intended use of the Electric Wheelchair (Model: BBR-LY-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

# K223393

# Prepared Date: Jan. 29,2023

# 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: | [e-mail] |
| Tel: | 86-13524910052 |

# 2. Device Identification

| 510(K) number: | K223393 |
|--------------------|---------------------|
| Trade/Device Name: | Electric Wheelchair |
| Models: | 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 |

# 3. Predicate Device

| 510(K) number: | K213383 |
|--------------------|---------------------|
| Device Name: | WHILL Model C2 |
| Manufacturer: | Whill, Inc. |
| 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 (Model: BBR-LY-01-01) 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 (Model: BBR-LY-01-01) is an indoor/outdoor, battery-operated, 2-wheel drive (rear-wheel drive) powered wheelchair.

lt 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 pad positioned on the right armrest, user can turn the wheelchair on, control the speed, and direct the movement.

The braking system employs an electromagnetic brake, when release the controller rocker, the electromagnetic brakes will be actuated, and the electric wheelchair will stop in several seconds. 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 (Model: BBR-LY-01-01) contains Bluetooth 4.1 BLE technology. The device can be controlled by the 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, controller rocker 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 automatically.

## 6. Compared to Predicate Device

Compared to the predicate devices, the subject device has the same intended use, similar product design, similar performance, same safety as the predicate device, the summarized comparison information is listed in the following table

| SE<br>Comparisons | Proposed Device<br>Electric Wheelchair<br>(Model: BBR-LY-01-01) | Primary Predicate Device<br>WHILL Model C2 | Similarities/<br>Differences |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 510(K) number | K223393 | K213383 | / |
| Indication for<br>Use | The intended use of the<br>Electric Wheelchair (Model:<br>BBR-LY-01-01) is to provide<br>outdoor and indoor mobility to<br>persons limited to a seated | The intended use of the Model<br>C2 powered wheelchair is to<br>provide outdoor and indoor<br>mobility to persons limited to a<br>seated position that are capable | Same |
| SE<br>Comparisons | Proposed Device<br>Electric Wheelchair<br>(Model: BBR-LY-01-01) | Primary Predicate Device<br>WHILL Model C2 | Similarities/<br>Differences |
| | position that are capable of<br>operating a powered<br>wheelchair. | 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 | 895 mm (Stowage)<br>1075 mm | 38.8 in (985.5mm) | Different<br>See Note 1 |
| Device Width | 628 mm | 21.8 in (553.7mm) | Different<br>See Note 1 |
| Device Height | 395 mm (Stowage)<br>930 mm | 29.3 - 37.2in<br>(744-945mm) | Different<br>See Note 1 |
| Stowage<br>Length | 895 mm | / | Different<br>See Note 1 |
| Stowage Width | 628 mm | / | Different<br>See Note 1 |
| Stowage<br>Height | 395 mm | / | Different<br>See Note 1 |
| Number of<br>wheels | 4 | 4 | Same |
| Front Wheel<br>Diameter | 10 in | 10.11 in | Different<br>See Note 2 |
| Rear Wheel<br>Diameter | 10 in | 10.43in | Different<br>See Note 2 |
| Ground<br>Clearance | 64 mm | 3 in (76mm) | Different<br>See Note 2 |
| Battery pack | 1 rechargeable lithium-ion<br>battery<br>Ratings: 24 V 20Ah | 1 rechargeable lithium-ion<br>battery<br>Ratings: 25.3 V 10.5Ah | Different<br>See Note 3 |
| Battery weight | 3.4kg | 6.0 lbs.(2.72kg) | Different<br>See Note 3 |
| Charger | Input: 100-240VAC<br>50-60Hz 1.9A<br>Output: 24V 4A | Type: off-board<br>Rated DC output voltage: 24.9V<br>DC<br>Rated current output: 2.4A DC | Different<br>See Note 3 |
| Maximum<br>Weight<br>Capacity | 120kg | 300lb (136kg) | Different<br>See Note 4 |
| SE<br>Comparisons | Proposed Device<br>Electric Wheelchair<br>(Model: BBR-LY-01-01) | Primary Predicate Device<br>WHILL Model C2 | Similarities/<br>Differences |
| Maximum<br>forward<br>speed<br>(maximum safe<br>speed) | 6km/h | 5 mph (8km/h) | Different<br>See Note 5 |
| Speed Settings | 5 | 4 | Different<br>See Note 5 |
| Braking<br>System | Electromagnetic | Electromagnetic | Same |
| Braking<br>mechanism in<br>case of<br>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<br>the motors to prevent rotation. | Normally closed brakes<br>(The "normally closed" brakes<br>are by default<br>engaged on the motors,<br>preventing rotation, when<br>the device is powered off or<br>when electrical power<br>is lost. | Same |
| Minimum<br>braking<br>distance from<br>max<br>speed | 120cm | 1500 mm (1.5 m) | Different<br>See Note 6 |
| Turning Radius | 760mm | 30in(762mm) | Different<br>See Note 1 |
| Obstacle<br>Climbing<br>Height (Highest<br>curb<br>clearance) | 45mm | 2in(50mm) | Different<br>See Note 1 |
| Drive system | 2 Wheel Drive (Rear wheel<br>drive) | 2 Wheel Drive (Rear wheel<br>drive) | Same<br>See Note 7 |
| folding<br>mechanism | Automatically fold/unfold drove<br>by motor | Without folding mechanism, the<br>seat height can be adjusted<br>manually | Same<br>See Note 8 |
| Dynamic<br>Stability | 6° | Measured posteriorly: 10°<br>Measured anteriorly: 10°<br>Measured sideways: 10° | Same<br>See Note 9 |
| Driving Range<br>(full<br>battery<br>charge)/<br>Maximum<br>distance<br>on fully battery<br>charge | 20.6km | 11 miles (17.7km) | Different<br>See Note 4 |
| SE<br>Comparisons | Proposed Device<br>Electric Wheelchair<br>(Model: BBR-LY-01-01) | Primary Predicate Device<br>WHILL Model C2 | Similarities/<br>Differences |
| On/Off Button | Yes, Power Button on the<br>control pad | Yes, Power Button on the<br>control pad. | Same |
| rocker Location | Right arm | Left or right arm | Different<br>The location<br>of rocker<br>does not<br>affect safety<br>and<br>effectiveness |
| Seat Widths | 425mm | 16in(406mm), 18in(457mm) and<br>20in(508mm) | Different<br>See Note 10 |
| Seat Depths | 425mm | 16in(406mm), 18in(457mm) and<br>20in(508mm) | Different<br>See Note 10 |
| Back support<br>Height | 455mm | 13.4in(340mm)-18(460mm) | Different<br>See Note 10 |
| Tail lamps (2) | White LED lights | Red LED lights | Different<br>See Note 11 |
| Operating<br>Conditions | -10°C~50°C | 5 to 104 degrees F (-15 to 40<br>degrees C) | Different<br>See Note 12 |
| Storage<br>Conditions | -40 °C~60 ° C | 5 to 104 degrees F (-15 to 40<br>degrees C) | Different<br>See Note 12 |
| Smartphone<br>App | iOS and Android | iOS and Android | Same |
| Wireless RF<br>frequency<br>range | 2.400GHz ~ 2.4835GHz | 2.402 GHz to 2.480 GHz | Different<br>See Note 13 |
| Wireless RF<br>maximum<br>output<br>power | +4dBm~-20dBm (in 4dB steps) | 5dBm | Different<br>See Note 13 |
| 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 | conforms to ISO 8191-1/8191-2<br>that is equivalent to ISO 7176-<br>16 | Same |
| Biocompatibility | wheelchair conforms to ISO<br>10993-5:2009 and ISO 10993-<br>10:2010 | wheelchair conforms to ISO<br>10993-5:2009 and ISO 10993-<br>10:2010 | Same |
| SE<br>Comparisons | Proposed Device<br>Electric Wheelchair<br>(Model: BBR-LY-01-01) | Primary Predicate Device<br>WHILL Model C2 | Similarities/<br>Differences |
| EMC | wheelchair conforms to ISO<br>7176-21:2009 | wheelchair conforms to ISO<br>7176-21:2009 | Same |
| Wireless<br>coexistence | wheelchair conforms to ANSI<br>C63.27-2017 | wheelchair conforms to ANSI<br>C63.27-2017 | Same |

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Note 1: The predicate device cannot be folded and can be disassembled, so it has no stowage dimension. The subject device can be folded and cannot be disassembled. The subject device complies with ISO 7176-5:2008 Wheelchairs – Part 5: Determination of dimensions, mass, and maneuverings space, these differences do not affect safety and effectiveness.

Note 2: The subject device complies with ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions, these differences do not affect safety and effectiveness.

Note 3: The battery and battery charger comply with ISO 7176-25: 2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs, these differences do not affect safety and effectiveness.

Note 4: The subject device complies with ISO 7176-4: 2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range, these differences do not affect safety and effectiveness.

Note 5: The subject device complies with ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs, these differences do not affect safety and effectiveness.

Note 6: The subject device complies with ISO 7176-3:2017 Wheelchairs - Part 3: Determination of effectiveness of brakes, this difference do not affect safety and effectiveness.

Note 7: The subject device complies with ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods, do not affect safety and effectiveness.

Note 8: The subject device complies with ISO 7176 series standard, the folding mechanism can bear the specify mass in intended environment, and it could not cause mechanic or other hazards, so this difference does not affect safety and effectiveness.

Note 9: The subject device complies with ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs, do not affect safety and effectiveness.

Note 10: The subject device complies with ISO 7176- 7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions, these differences do not affect safety and effectiveness.

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Traditional 510(k) Submission of Electric Wheelchair

Note 11: The subject device employs a white LED light, the color is different from predicate device, its function is that a wheelchair user can be seen, so this do not affect safety and effectiveness.

Note 12: The subject device complies with ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs, these differences do not affect safety and effectiveness.

Note 13: The subject device complies with FCC 47 CFR 15.247 and RF exposure requirements, ANSI C63.27 wireless coexistence and ISO 7176-12:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs, these differences do not affect safety and effectiveness.

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-LY-01-01) 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 strengths

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

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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 IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

FCC RF

FCC CFR TITLE 47 PART 15 SUBPART C FCC CFR TITLE 47 PART 2.1093

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 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

#### 9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device Electric Wheelchair (Model: BBR-LY-01) is as safe, as effective, and performs as well the legally marketed predicated device WHILL Model C2 (K213383).