(128 days)
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.
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.
This document describes the FDA's 510(k) clearance for the Shanghai BangBang Robotics Co., Ltd. Electric Wheelchair (Model: BBR-LY-01-01). As such, it focuses on demonstrating "substantial equivalence" to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in the manner an AI/ML algorithm submission would.
Therefore, many of the requested points are not applicable to this type of regulatory submission for a physical medical device. However, I can extract the relevant information regarding performance and testing.
1. A table of acceptance criteria and the reported device performance
For a physical device like an electric wheelchair, "acceptance criteria" are generally compliance with recognized consensus standards. The performance is reported as meeting these standards.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Compliance) |
|---|---|
| Static Stability (ISO 7176-1:2014) | Complies |
| Dynamic Stability (ISO 7176-2:2017) | Complies (specifically tested 6° dynamic stability vs. predicate's 10°) |
| Effectiveness of Brakes (ISO 7176-3:2017) | Complies (minimum braking distance 120cm vs. predicate's 1500mm) |
| Energy Consumption & Theoretical Distance Range (ISO 7176-4:2008) | Complies (driving range 20.6km vs. predicate's 17.7km) |
| Overall Dimensions, Mass, and Maneuvering Space (ISO 7176-5:2008) | Complies (dimensions differ from predicate but meet standard) |
| Maximum Speed, Acceleration, and Deceleration (ISO 7176-6:2018) | Complies (max forward speed 6km/h vs. predicate's 8km/h) |
| Measurement of Seating and Wheel Dimensions (ISO 7176-7:1998) | Complies (seating/wheel dimensions differ from predicate but meet standard) |
| Static, Impact, and Fatigue Strengths (ISO 7176-8:2014) | Complies |
| Climatic Tests (ISO 7176-9:2009) | Complies (operating/storage conditions differ from predicate but meet standard) |
| Obstacle-Climbing Ability (ISO 7176-10:2008) | Complies |
| Test dummies (ISO 7176-11:2012) | Complies |
| Determination of coefficient of friction of test surfaces (ISO 7176-13:1989) | Complies |
| Power and Control Systems (ISO 7176-14:2008) | Complies |
| Information Disclosure, Documentation and Labeling (ISO 7176-15:1996) | Complies |
| Resistance to Ignition of Postural Support Devices (ISO 7176-16:2012) | Complies |
| Set-up Procedures (ISO 7176-22:2014) | Complies |
| Batteries and Chargers (ISO 7176-25:2013) | Complies |
| Electromagnetic Compatibility (ISO 7176-21:2009 & IEC 60601-1-2:2014) | Complies |
| FCC RF Compliance (FCC CFR TITLE 47 PART 15 SUBPART C, PART 2.1093) | Complies (wireless RF frequency/output power differ from predicate but meet standard) |
| Wireless Coexistence (ANSI C63.27-2017) | Complies |
| Biocompatibility (ISO 10993-5:2009 & ISO 10993-10:2010) | Complies |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is typically not included in a 510(k) summary for a non-software medical device. Testing against ISO standards usually involves a representative number of physical units, not a "test set" of data in the AI/ML sense. The testing would have been done by the manufacturer (Shanghai BangBang Robotics Co., Ltd. in China) and verified by a recognized testing body.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable. For a physical device, "ground truth" is established by the direct physical measurement and performance testing against the specifications outlined in the international consensus standards (e.g., measuring stability, braking distance, dimensions). This does not involve expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in image interpretation or similar diagnostic tasks, typically for AI/ML algorithms. This is not relevant for the performance testing of an electric wheelchair.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. MRMC studies are specific to evaluating the impact of AI on human readers (e.g., radiologists interpreting images). This device is a physical product (electric wheelchair) and does not involve "human readers" or "AI assistance" in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is an electric wheelchair, not an algorithm. While it has a control system and Bluetooth connectivity, its primary function is mechanical mobility, and it is always operated with a human in the loop (the user or a remote controller).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with international consensus standards (ISO 7176 series and others) through objective performance testing and measurement. For example, the braking distance being 120cm is a factual measurement, not an expert opinion or pathology finding.
8. The sample size for the training set
Not Applicable. This is not an AI/ML algorithm, so there is no "training set."
9. How the ground truth for the training set was established
Not Applicable. No training set exists for this type of device submission.
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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 and Human Services logo. To the right of that is the FDA logo, which 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.
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 (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 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, SongjiangDistrict, 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: | 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
| SEComparisons | Proposed DeviceElectric Wheelchair(Model: BBR-LY-01-01) | Primary Predicate DeviceWHILL Model C2 | Similarities/Differences |
|---|---|---|---|
| 510(K) number | K223393 | K213383 | / |
| Indication forUse | The intended use of theElectric Wheelchair (Model:BBR-LY-01-01) is to provideoutdoor and indoor mobility topersons limited to a seated | The intended use of the ModelC2 powered wheelchair is toprovide outdoor and indoormobility to persons limited to aseated position that are capable | Same |
| SEComparisons | Proposed DeviceElectric Wheelchair(Model: BBR-LY-01-01) | Primary Predicate DeviceWHILL Model C2 | Similarities/Differences |
| position that are capable ofoperating a poweredwheelchair. | of operating a poweredwheelchair. | ||
| Product code | ITI | ITI | Same |
| Class | II | II | Same |
| RegulationNumber | 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)1075 mm | 38.8 in (985.5mm) | DifferentSee Note 1 |
| Device Width | 628 mm | 21.8 in (553.7mm) | DifferentSee Note 1 |
| Device Height | 395 mm (Stowage)930 mm | 29.3 - 37.2in(744-945mm) | DifferentSee Note 1 |
| StowageLength | 895 mm | / | DifferentSee Note 1 |
| Stowage Width | 628 mm | / | DifferentSee Note 1 |
| StowageHeight | 395 mm | / | DifferentSee Note 1 |
| Number ofwheels | 4 | 4 | Same |
| Front WheelDiameter | 10 in | 10.11 in | DifferentSee Note 2 |
| Rear WheelDiameter | 10 in | 10.43in | DifferentSee Note 2 |
| GroundClearance | 64 mm | 3 in (76mm) | DifferentSee Note 2 |
| Battery pack | 1 rechargeable lithium-ionbatteryRatings: 24 V 20Ah | 1 rechargeable lithium-ionbatteryRatings: 25.3 V 10.5Ah | DifferentSee Note 3 |
| Battery weight | 3.4kg | 6.0 lbs.(2.72kg) | DifferentSee Note 3 |
| Charger | Input: 100-240VAC50-60Hz 1.9AOutput: 24V 4A | Type: off-boardRated DC output voltage: 24.9VDCRated current output: 2.4A DC | DifferentSee Note 3 |
| MaximumWeightCapacity | 120kg | 300lb (136kg) | DifferentSee Note 4 |
| SEComparisons | Proposed DeviceElectric Wheelchair(Model: BBR-LY-01-01) | Primary Predicate DeviceWHILL Model C2 | Similarities/Differences |
| Maximumforwardspeed(maximum safespeed) | 6km/h | 5 mph (8km/h) | DifferentSee Note 5 |
| Speed Settings | 5 | 4 | DifferentSee Note 5 |
| BrakingSystem | Electromagnetic | Electromagnetic | Same |
| Brakingmechanism incase ofelectricalBrake Failure | Normally closed brakes beemployed. Whenthe device is powered off orwhen electrical poweris lost, the brakes engaged onthe motors to prevent rotation. | Normally closed brakes(The "normally closed" brakesare by defaultengaged on the motors,preventing rotation, whenthe device is powered off orwhen electrical poweris lost. | Same |
| Minimumbrakingdistance frommaxspeed | 120cm | 1500 mm (1.5 m) | DifferentSee Note 6 |
| Turning Radius | 760mm | 30in(762mm) | DifferentSee Note 1 |
| ObstacleClimbingHeight (Highestcurbclearance) | 45mm | 2in(50mm) | DifferentSee Note 1 |
| Drive system | 2 Wheel Drive (Rear wheeldrive) | 2 Wheel Drive (Rear wheeldrive) | SameSee Note 7 |
| foldingmechanism | Automatically fold/unfold droveby motor | Without folding mechanism, theseat height can be adjustedmanually | SameSee Note 8 |
| DynamicStability | 6° | Measured posteriorly: 10°Measured anteriorly: 10°Measured sideways: 10° | SameSee Note 9 |
| Driving Range(fullbatterycharge)/Maximumdistanceon fully batterycharge | 20.6km | 11 miles (17.7km) | DifferentSee Note 4 |
| SEComparisons | Proposed DeviceElectric Wheelchair(Model: BBR-LY-01-01) | Primary Predicate DeviceWHILL Model C2 | Similarities/Differences |
| On/Off Button | Yes, Power Button on thecontrol pad | Yes, Power Button on thecontrol pad. | Same |
| rocker Location | Right arm | Left or right arm | DifferentThe locationof rockerdoes notaffect safetyandeffectiveness |
| Seat Widths | 425mm | 16in(406mm), 18in(457mm) and20in(508mm) | DifferentSee Note 10 |
| Seat Depths | 425mm | 16in(406mm), 18in(457mm) and20in(508mm) | DifferentSee Note 10 |
| Back supportHeight | 455mm | 13.4in(340mm)-18(460mm) | DifferentSee Note 10 |
| Tail lamps (2) | White LED lights | Red LED lights | DifferentSee Note 11 |
| OperatingConditions | -10°C~50°C | 5 to 104 degrees F (-15 to 40degrees C) | DifferentSee Note 12 |
| StorageConditions | -40 °C~60 ° C | 5 to 104 degrees F (-15 to 40degrees C) | DifferentSee Note 12 |
| SmartphoneApp | iOS and Android | iOS and Android | Same |
| Wireless RFfrequencyrange | 2.400GHz ~ 2.4835GHz | 2.402 GHz to 2.480 GHz | DifferentSee Note 13 |
| Wireless RFmaximumoutputpower | +4dBm~-20dBm (in 4dB steps) | 5dBm | DifferentSee Note 13 |
| Wirelessoperatingrange | 10m | 10m | Same |
| Non clinical testing | |||
| Performance | wheelchair conforms to theISO 7176 standards | wheelchair conforms to the ISO7176 standards | Same |
| FlammabilityTesting | wheelchair conforms to theISO 7176-16 standards | conforms to ISO 8191-1/8191-2that is equivalent to ISO 7176-16 | Same |
| Biocompatibility | wheelchair conforms to ISO10993-5:2009 and ISO 10993-10:2010 | wheelchair conforms to ISO10993-5:2009 and ISO 10993-10:2010 | Same |
| SEComparisons | Proposed DeviceElectric Wheelchair(Model: BBR-LY-01-01) | Primary Predicate DeviceWHILL Model C2 | Similarities/Differences |
| EMC | wheelchair conforms to ISO7176-21:2009 | wheelchair conforms to ISO7176-21:2009 | Same |
| Wirelesscoexistence | wheelchair conforms to ANSIC63.27-2017 | wheelchair conforms to ANSIC63.27-2017 | 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).
§ 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).