(133 days)
No
The description focuses on standard power wheelchair components, control mechanisms (joystick, BLE remote), and compliance with relevant ISO standards. There is no mention of AI, ML, or any features that would suggest adaptive learning, predictive capabilities, or complex decision-making beyond basic motor control and braking. The performance studies listed are standard tests for wheelchair safety and functionality, not AI/ML model validation.
Yes
The device is described as a power wheelchair intended to provide mobility to disabled or elderly individuals, which directly addresses a health-related need by aiding in their physical function and independence. These types of devices are commonly classified as therapeutic under medical device regulations.
No
The device description and intended use clearly state that it is a power wheelchair designed for mobility, not to diagnose a condition. The performance studies listed are for safety and functional aspects of the wheelchair, not for diagnostic capabilities.
No
The device description clearly outlines numerous hardware components including motors, brakes, battery, frame, wheels, and a physical joystick. While it mentions a remote controller via BLE, the core functionality and description are centered around a physical power wheelchair.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to a disabled or elderly person. This is a physical function, not a diagnostic one.
- Device Description: The description details a mechanical and electrical device for transportation. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.).
- Performance Studies: The performance studies listed are related to the physical and electrical performance and safety of a wheelchair (stability, speed, braking, battery, etc.), not diagnostic accuracy or analysis of biological data.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, providing diagnostic information, or any other characteristic typically associated with IVD devices.
In summary, the power wheelchair described is a medical device intended for mobility assistance, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The power wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The power wheelchair, model name: D10, D12, D15, D17, D20, D37, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.
The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
The power wheelchair, model name: D10, D12, D15, D17, D20, D37, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design.
The power wheelchair (Model D10, D12, D15, D17, D20, D37) can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
The D17 power wheelchair has an additional headrest and its seat unit can be adjusted by a remote control key to a largest angle of 30°.
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
disabled or elderly person limited to a seated position
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)
Study Type: Performance testing - bench, Biocompatibility
Key Results:
The power wheelchair performed as intended and is safe and effective.
The proposed device and predicate device are complying to the same ISO standards, ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-14:2022, ISO 7176-15:1996, ISO 16840-10:2021, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 62133-2:2017, IEC 60601-1-2: 2020 and FDA guidance submission for power wheelchair.
The performance testing demonstrates that the subject device is substantially equivalent to the predicate devices regarding Static ability, The Dynamic stability, Brake performance, Theoretical distance range, Dimension and weight, Maximum speed, Dimension of wheel Static, impact and fatigue strengths, Climatic tests, Obstacle-climbing ability, Dummy, friction of test surfaces, Power and control systems, Documentation and labeling, Resistance to ignition, Electromagnetic Compatibility and Electrical Safety, Batteries and chargers.
The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO10993-10:2010/ ISO 10993-23:2021.
The proposed device has additional Bluetooth remote control way to operate the wheelchair which is different with the predicate device, while is substantially equivalent to the reference device. Although the remote-control tool is different, the Bluetooth skill is the same. The cybersecurity has been validated to be effective and do not raise new issues of safety or effectiveness.
The non-clinical laboratory data support the safety and performance of the subject device and demonstrate that the subject device should perform as intended in the specified use conditions.
Performance testing-bench
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in accordance with ISO 14971: 2019.
- Software validation
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric 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 dimensions, mass and maneuvering 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 strength
- 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 7176-14:2022 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 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method.
- ISO 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
- ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020. ●
Biocompatibility of patient-contacting material
Biocompatibility Tests were carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021) and irritation (ISO 10993-23: 2021). Additionally, the low-biocompatibility-risk materials policy in Attachment G of FDA's 2023 Guidance on "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" was invoked for eligible tissue-contacting materials, while the biocompatibility of the footrest was established via claim of identical materials to legally marketed comparator device K241854 (Power Wheelchair).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 31, 2024
Anhui JBH Medical Apparatus Co., Ltd. % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1 401 , Dongfang Building, 1500# Century Ave. Shanghai. 200122 China
Re: K242468
Trade/Device Name: Power Wheelchair (D10, D12, D15, D17, D20, D37) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 2, 2024 Received: December 2, 2024
Dear Ivy Wang:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
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
Enclosure
3
Indications for Use
510(k) Number (if known) K242468
Device Name Power Wheelchair (D10, D12, D15, D17, D20, D37)
Indications for Use (Describe)
The power wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
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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4
510(k) Summary
K242468
SUBMITTER l.
Name: Anhui JBH Medical Apparatus Co., Ltd.
Address: No. 116 Qicang Road, Industrial District, Ming Guang City, Chuzhou, Anhui, China
Name of contact person: Wei Yuanwei
Telephone: +86-0550-8108866
Fax: +86-0550-8106688
Email: outreach@jbhmedical.com
Date prepared: 2024-12-30
II. Device
Device trade name: Power wheelchair
Models: D10, D12, D15, D17, D20, D37
Classification name: Powered wheelchair
Regulation class: 2
Regulation number: 21CFR 890.3860
Panel: Physical Medicine
Product code: ITI
III. Predicate device
Portable Folding Electric Wheelchair (Model: DC01)
Anhui JBH Medical Apparatus Co., Ltd
Reference device
Electric Wheelchair (Model: BBR-LY-01-01)
Shanghai BangBang Robotics Co., Ltd.
5
IV. Device description
The power wheelchair, model name: D10, D12, D15, D17, D20, D37, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.
The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
The power wheelchair, model name: D10, D12, D15, D17, D20, D37, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design.
The power wheelchair (Model D10, D12, D15, D17, D20, D37) can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
The D17 power wheelchair has an additional headrest and its seat unit can be adjusted by a remote control key to a largest angle of 30°.
V. Indication for use
The power wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
6
VI. Comparison of technological characteristics with the predicate device
Table 1 General Comparison
| Attribute | Subject device | Predicate device | Reference device | Discussion/Conclusion |
|---|---|---|---|---|
| Manufacturer | Anhui JBH Medical Apparatus | |||
| Co., Ltd. | Anhui JBH Medical Apparatus | |||
| Co., Ltd. | Shanghai BangBang Robotics / | |||
| Co., Ltd. | / | |||
| Proprietary | ||||
| name, model | Power Wheelchair | |||
| D10, D12, D15, D17, D20, D37 | power wheelchair, DC01 | Electric Wheelchair | ||
| (Model: BBR-LY-01-01) | / | |||
| 510(k) number | TBD | K212092 | K223393 | / |
| Device | ||||
| classification | ||||
| name | Class II | Class II | Class II | Same |
| Classification | ||||
| regulations | 21 CFR 890.3860 | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | ITI | Same |
| Indication for | ||||
| use | The Power wheelchair is a motor | |||
| driven, indoor and outdoor | ||||
| transportation vehicle with the | ||||
| intended use to provide mobility | ||||
| to a disabled or elderly person | ||||
| limited to a seated position. | The wheelchair (Model: DC01) is | |||
| a motor driven, indoor and | ||||
| outdoor transportation vehicle | ||||
| with the intended use to provide | ||||
| mobility to a disabled or elderly | ||||
| person limited to a seated | ||||
| position. | 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. | Same | |||
| Intended user | disabled or elderly person | |||
| limited to a seated position | disabled or elderly person | |||
| limited to a seated position | disabled or elderly person | |||
| limited to a seated position | Same |
7
| Use condition | indoor and outdoor use | indoor and outdoor use | indoor and outdoor use | Same |
|---|---|---|---|---|
| Type of use | OTC | OTC | OTC | Same |
Table 2 Basic Parameters Comparison
| Attribute | Subject device | Predicate device | Reference device | Discussion/Conclusion |
|---|---|---|---|---|
| Device length | 950mm – 1110mm | Not publicly available | 1075mm | Minor difference on dimension do not affect safety and effectiveness. |
| Device Width | 610mm – 660mm | Not publicly available | 628mm | All safety and performance have been validated with the maximum rated weight dummy. |
| Stowage Length | 620mm – 1100mm | Not publicly available | 895mm | |
| Stowage width | 280mm – 645mm | Not publicly available | 628mm | |
| Stowage height | 260mm -800mm | Not publicly available | 395mm | |
| Ground clearance | 50mm - 113mm | Not publicly available | Not publicly available | Minor difference on ground clearance do not affect effectiveness and safety performance. All safety and performance have been validated with the maximum rated weight dummy. |
| Number of wheels | 4 | 4 | 4 | Same |
| Front wheel size/type | 7" /PU Solid tire for D10, D12, D17, D20, D37 | |||
| 8" /PU solid tire for D15 | 7" /PU Solid tire | 10 in | Minor difference on wheel size do not affect effectiveness and safety | |
| Rear | ||||
| wheel | ||||
| size/type | 8" /PU Solid tire for D20, D37 | |||
| 9.6" /PU Solid tire for D15 | ||||
| 12.5"/ PU solid tire for D10, | ||||
| D12, D17 | 8" /PU Solid tire | 10 in | performance. All safety and performance have been validated with the maximum rated weight dummy. | |
| Function of | ||||
| wheels | Front wheels: driven wheels suitable for rotation, acceleration, retrograde | |||
| Rear wheels: driving wheels to control the speed and direction | Front wheels: driven wheels suitable for rotation, acceleration, retrograde | |||
| Rear wheels: driving wheels to control the speed and direction | Front wheels: driven wheels suitable for rotation, acceleration, retrograde | |||
| Rear wheels: driving wheels to control the speed and direction | Same | |||
| Frame design | The frame of the wheelchair is type capable of front and rear close. The main part of the frame can be folded for saving space and convenient storage and transportation. | The frame of the wheelchair is type capable of front and rear close. The main part of the frame can be folded for saving space and convenient storage and transportation. | The frame of the wheelchair is type capable of front and rear close. | Same |
| Folding | ||||
| mechanism | Manually fold/ expand for model D10, D12, D15, D17, D20, D37 | |||
| Automatically fold/ expand drove by motor for Model D15 | Manually fold/ expand | Automatically fold/ expand drove by motor | Same | |
| Movement | ||||
| control method | By Joystick control and Bluetooth remote controller | By Joystick control | By Joystick control and Bluetooth smartphone app control | Same with reference device, has one more control method through |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Brake system | Intelligent electromagnetic brake system | Intelligent regenerative Electromagnetic brake | Electromagnetic | Same |
| Max speed forward | Up to 6 km/h (3.75 mph), continuously adjustable | Up to 6 km/h (3.75 mph), variable | 6km/h | Same |
| Armrest cushion | Polyurethane (PU) | Polyurethane (PU) | Not applicable | Same |
| Speed settings | 5 | Not publicly available | 5 | Same |
| Maximum safe operational incline degree | 8 ° | 8 ° | 6 ° | Same |
| Electronic controller | Dual Drive Controller for Brushless Motor | Dual Drive Controller for Brushless Motor | Not applicable | Same |
| Maximum distance of travel on the fully charged battery | 20km | 20 km | 20.6 km | Same |
| Differences | ||||
| Main | ||||
| frame | ||||
| material | Aluminum alloy | Carbon fiber | Not applicable | Different material used for |
| frame, that such | ||||
| difference will not impact | ||||
| the safety and | ||||
| effectiveness of the | ||||
| subject device as the | ||||
| performance tests are | ||||
| conducted according to | ||||
| Battery | li-ion battery; rechargeable, | |||
| 24 VDC 6Ah*2 | Li-ion, Rechargeable; 24 VDC | |||
| 20Ah | 1 rechargeable | |||
| lithium-ion | ||||
| battery | ||||
| Ratings: 24 V 20Ah | ISO 7176 series. | |||
| Same rated voltage with | ||||
| different power capacity, | ||||
| both batteries are tested | ||||
| according to IEC62133-2, | ||||
| this difference will not | ||||
| affect the safety and | ||||
| performance of the | ||||
| subject device. | ||||
| Battery charger | Off-board charger | |||
| Input: 100-240Vac, 50/60Hz, | ||||
| 1.5A | ||||
| Output: 24 Vdc, 2A | Off-board charger | |||
| Input: 100-240V, 50/60Hz, 1.5A | ||||
| Output: 24 Vdc, 2A | Input: 100-240VAC | |||
| 50-60Hz 1.9A | ||||
| Output: 24V 4A | More wide range of input | |||
| voltage in the device | ||||
| which will not cause new | ||||
| safety and effectiveness | ||||
| concerns raised. | ||||
| Minimum braking | ||||
| distance | ||||
| from | ||||
| maximum speed | Forward: > Performance testing-bench |
The following performance data were provided to verify that the subject device met all design
specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in accordance with ISO 14971: 2019.
- . Software validation
- . ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric 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 dimensions, mass and maneuvering 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 strength
- . 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 7176-14:2022 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.
16
- . ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method.
- . ISO 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
- . ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- . IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020. ●
Biocompatibility of patient-contacting material A
Biocompatibility Tests were carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021) and irritation (ISO 10993-23: 2021). Additionally, the low-biocompatibility-risk materials policy in Attachment G of FDA's 2023 Guidance on "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" was invoked for eligible tissue-contacting materials, while the biocompatibility of the footrest was established via claim of identical materials to legally marketed comparator device K241854 (Power Wheelchair).
IX. Summary of clinical testing
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device.
X. Conclusions
The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K212092.