(128 days)
WHILL Model C2 (K213383)
No
The device description focuses on standard mechanical and electrical components, control systems, and Bluetooth connectivity for remote control. There is no mention of AI or ML algorithms for tasks like navigation, obstacle detection, or user adaptation.
No
The device is an electric wheelchair designed to provide mobility, not to treat or diagnose a medical condition.
No
The device description indicates it is an electric wheelchair designed for mobility, not for diagnosing medical conditions. Its functions (mobility, speed control, braking, battery status view) do not involve detecting, monitoring, or analyzing physiological parameters for diagnostic purposes.
No
The device description clearly outlines multiple hardware components including a seat system, control system, braking system, drive system, battery, motors, and Bluetooth technology. While it includes a smartphone app for remote control, the core device is a physical electric wheelchair.
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 Electric Wheelchair (Model: BBR-LY-01-01) is a mobility aid. Its function is to provide transportation and support for individuals with limited mobility. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states "to provide outdoor and indoor mobility to persons limited to a seated position". This is a functional purpose, not a diagnostic one.
- Device Description: The description details mechanical, electrical, and control systems related to movement and operation, not diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided information, the Electric Wheelchair (Model: BBR-LY-01-01) is a medical device, but it falls under the category of a mobility aid, not an In Vitro Diagnostic.
N/A
Intended Use / Indications 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.
Product codes
ITI
Device Description
The Electric Wheelchair (Model: BBR-LY-01-01) 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 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.
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 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
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
Key results: 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 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.
1
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
2
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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3
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 |
| 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: | 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 |
4
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
Comparisons | Proposed Device
Electric Wheelchair
(Model: BBR-LY-01-01) | Primary Predicate Device
WHILL Model C2 | Similarities/
Differences |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 510(K) number | K223393 | K213383 | / |
| 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 | The intended use of the Model
C2 powered wheelchair is to
provide outdoor and indoor
mobility to persons limited to a
seated position that are capable | Same |
| SE
Comparisons | Proposed Device
Electric Wheelchair
(Model: BBR-LY-01-01) | Primary Predicate Device
WHILL Model C2 | Similarities/
Differences |
| | position that are capable of
operating a powered
wheelchair. | of operating a powered
wheelchair. | |
| Product code | ITI | ITI | Same |
| Class | II | II | Same |
| Regulation
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)
1075 mm | 38.8 in (985.5mm) | Different
See Note 1 |
| Device Width | 628 mm | 21.8 in (553.7mm) | Different
See Note 1 |
| Device Height | 395 mm (Stowage)
930 mm | 29.3 - 37.2in
(744-945mm) | Different
See Note 1 |
| Stowage
Length | 895 mm | / | Different
See Note 1 |
| Stowage Width | 628 mm | / | Different
See Note 1 |
| Stowage
Height | 395 mm | / | Different
See Note 1 |
| Number of
wheels | 4 | 4 | Same |
| Front Wheel
Diameter | 10 in | 10.11 in | Different
See Note 2 |
| Rear Wheel
Diameter | 10 in | 10.43in | Different
See Note 2 |
| Ground
Clearance | 64 mm | 3 in (76mm) | Different
See Note 2 |
| Battery pack | 1 rechargeable lithium-ion
battery
Ratings: 24 V 20Ah | 1 rechargeable lithium-ion
battery
Ratings: 25.3 V 10.5Ah | Different
See Note 3 |
| Battery weight | 3.4kg | 6.0 lbs.(2.72kg) | Different
See Note 3 |
| Charger | Input: 100-240VAC
50-60Hz 1.9A
Output: 24V 4A | Type: off-board
Rated DC output voltage: 24.9V
DC
Rated current output: 2.4A DC | Different
See Note 3 |
| Maximum
Weight
Capacity | 120kg | 300lb (136kg) | Different
See Note 4 |
| SE
Comparisons | Proposed Device
Electric Wheelchair
(Model: BBR-LY-01-01) | Primary Predicate Device
WHILL Model C2 | Similarities/
Differences |
| Maximum
forward
speed
(maximum safe
speed) | 6km/h | 5 mph (8km/h) | Different
See Note 5 |
| Speed Settings | 5 | 4 | Different
See Note 5 |
| Braking
System | Electromagnetic | Electromagnetic | Same |
| Braking
mechanism in
case of
electrical
Brake Failure | Normally closed brakes be
employed. When
the device is powered off or
when electrical power
is lost, the brakes engaged on
the motors to prevent rotation. | Normally closed brakes
(The "normally closed" brakes
are by default
engaged on the motors,
preventing rotation, when
the device is powered off or
when electrical power
is lost. | Same |
| Minimum
braking
distance from
max
speed | 120cm | 1500 mm (1.5 m) | Different
See Note 6 |
| Turning Radius | 760mm | 30in(762mm) | Different
See Note 1 |
| Obstacle
Climbing
Height (Highest
curb
clearance) | 45mm | 2in(50mm) | Different
See Note 1 |
| Drive system | 2 Wheel Drive (Rear wheel
drive) | 2 Wheel Drive (Rear wheel
drive) | Same
See Note 7 |
| folding
mechanism | Automatically fold/unfold drove
by motor | Without folding mechanism, the
seat height can be adjusted
manually | Same
See Note 8 |
| Dynamic
Stability | 6° | Measured posteriorly: 10°
Measured anteriorly: 10°
Measured sideways: 10° | Same
See Note 9 |
| Driving Range
(full
battery
charge)/
Maximum
distance
on fully battery
charge | 20.6km | 11 miles (17.7km) | Different
See Note 4 |
| SE
Comparisons | Proposed Device
Electric Wheelchair
(Model: BBR-LY-01-01) | Primary Predicate Device
WHILL Model C2 | Similarities/
Differences |
| On/Off Button | Yes, Power Button on the
control pad | Yes, Power Button on the
control pad. | Same |
| rocker Location | Right arm | Left or right arm | Different
The location
of rocker
does not
affect safety
and
effectiveness |
| Seat Widths | 425mm | 16in(406mm), 18in(457mm) and
20in(508mm) | Different
See Note 10 |
| Seat Depths | 425mm | 16in(406mm), 18in(457mm) and
20in(508mm) | Different
See Note 10 |
| Back support
Height | 455mm | 13.4in(340mm)-18(460mm) | Different
See Note 10 |
| Tail lamps (2) | White LED lights | Red LED lights | Different
See Note 11 |
| Operating
Conditions | -10°C50°C | 5 to 104 degrees F (-15 to 4060 ° C | 5 to 104 degrees F (-15 to 40
degrees C) | Different
See Note 12 |
| Storage
Conditions | -40 °C
degrees C) | Different
See Note 12 |
| Smartphone
App | iOS and Android | iOS and Android | Same |
| Wireless RF
frequency
range | 2.400GHz ~ 2.4835GHz | 2.402 GHz to 2.480 GHz | Different
See Note 13 |
| Wireless RF
maximum
output
power | +4dBm~-20dBm (in 4dB steps) | 5dBm | Different
See Note 13 |
| Wireless
operating
range | 10m | 10m | Same |
| Non clinical testing | | | |
| Performance | wheelchair conforms to the
ISO 7176 standards | wheelchair conforms to the ISO
7176 standards | Same |
| Flammability
Testing | wheelchair conforms to the
ISO 7176-16 standards | conforms to ISO 8191-1/8191-2
that is equivalent to ISO 7176-
16 | Same |
| Biocompatibility | wheelchair conforms to ISO
10993-5:2009 and ISO 10993-
10:2010 | wheelchair conforms to ISO
10993-5:2009 and ISO 10993-
10:2010 | Same |
| SE
Comparisons | Proposed Device
Electric Wheelchair
(Model: BBR-LY-01-01) | Primary Predicate Device
WHILL Model C2 | Similarities/
Differences |
| EMC | wheelchair conforms to ISO
7176-21:2009 | wheelchair conforms to ISO
7176-21:2009 | Same |
| Wireless
coexistence | wheelchair conforms to ANSI
C63.27-2017 | wheelchair conforms to ANSI
C63.27-2017 | Same |
5
6
7
8
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.
9
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
10
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).