(99 days)
Not Found
No
The description focuses on mechanical and electrical components and control via a joystick and tiller console, with no mention of AI or ML capabilities. Performance studies are bench tests and standard compliance, not AI/ML validation.
No
A therapeutic device is generally defined as one that treats, prevents, or diagnoses a disease or condition. This power wheelchair is intended for mobility assistance, not treatment or diagnosis.
No
Explanation: The device description clearly states its purpose is to provide mobility to disabled or elderly individuals. It does not mention any function related to diagnosing diseases, conditions, or injuries.
No
The device description clearly outlines numerous hardware components including wheels, frame, motors, battery, and a physical control system (joystick, throttle lever, speed control dial, handle). While software is mentioned in the performance studies section (Software validation), the core functionality and physical form of the device are hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to disabled or elderly persons. This is a physical function, not a diagnostic one.
- Device Description: The description details a mechanical and electrical device for transportation. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This power wheelchair does none of these things.
- Performance Studies: The performance studies focus on the physical and mechanical aspects of the wheelchair (stability, braking, speed, etc.), not on diagnostic accuracy or analytical performance.
In summary, the power wheelchair is a mobility aid, not a device used for in vitro diagnostic testing.
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
ITI
Device Description
The D25 power wheelchair is a four wheeled personal mobile device with a complementary chair support system that is powered by two motors. The traveling speed is controlled by the motor, and the traveling direction is controlled by the passenger. This product is a device suitable for disabled people with mobility difficulties and elderly people and it is intended to provide mobility to a disabled or elderly person limited to a seated position. The power wheelchair can be travelled on flat and obstacle ground surface, and direction and speed of the wheelchair can be controlled by the passenger's hand with the help of the joystick. The device can be used to provide indoor and outdoor mobility at a certain distance but not allowed to be travelled on the road or highway.
The wheelchair (Model D25) has a base with aluminum alloy frame, two front wheels, two rear wheels, a seat, an adjustable steering column, a tiller console, two electric motors, an electromagnetic brake, 1 rechargeable Lithium-Ion Battery with an off-board charger. The movement of the wheelchair is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually.
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 / indoor and outdoor
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)
The subject device complied with the requirements of 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, ISO10993-5:2009, ISO 10993-10:2021, ISO 10993-23: 2021, IEC60601-1-2: 2020. Non-clinical performance testing included: Risk Analysis developed in accordance with ISO 14971: 2019, Software validation, and tests based on the ISO standards listed above covering static stability, dynamic stability, brake effectiveness, energy consumption, dimensions, mass and maneuvering space, maximum speed, acceleration and deceleration, seating and wheel dimensions, static, impact and fatigue strength, climatic tests, obstacle-climbing ability, test dummies, coefficient of friction, power and control systems, information disclosure, documentation and labeling, resistance to ignition of postural support devices, and electromagnetic compatibility. Biocompatibility Tests are 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). No animal study and clinical studies were available or required. The nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K113463.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
October 4, 2024
Anhui JBH Medical Apparatus Co., Ltd. % Ivv Wang Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1 401, Dongfang Building, 1500# Century Ave. Shanghai. 200122 China
Re: K241854
Trade/Device Name: Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 6, 2024 Received: September 6, 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.
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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" (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 (OS) 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 QS 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 Rule"). 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-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 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-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Power Wheelchair
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
l. SUBMITTER
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: +86-0550-8106688
Date prepared: 2024-6-26
II. Device
Device trade name: Power wheelchair Model: D25 Classification name: Powered wheelchair Regulation class: 2 Regulation number: 21CFR 890.3860 Panel: Physical Medicine Product code: ITI
III. Predicate device
K113463 Power Wheelchair, PL001
SUZHOU KD Medical Appliance Co. Ltd.
IV. Device description
The D25 power wheelchair is a four wheeled personal mobile device with a complementary chair support system that is powered by two motors. The traveling speed is controlled by the motor, and the traveling direction is controlled by the passenger. This product is a device suitable for disabled people with mobility difficulties and elderly people and it is intended to provide mobility to a disabled or elderly person limited to a seated position. The power wheelchair can be travelled on flat and obstacle ground surface, and direction and speed of
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the wheelchair can be controlled by the passenger's hand with the help of the joystick. The device can be used to provide indoor and outdoor mobility at a certain distance but not allowed to be travelled on the road or highway.
The wheelchair (Model D25) has a base with aluminum alloy frame, two front wheels, two rear wheels, a seat, an adjustable steering column, a tiller console, two electric motors, an electromagnetic brake, 1 rechargeable Lithium-lon Battery with an off-board charger. The movement of the wheelchair is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually.
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.
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Manufacturer | Anhui JBH Medical | ||
| Apparatus Co., Ltd. | SUZHOU KD Medical | ||
| Appliance Co. Ltd. | / | ||
| Proprietary name, model | Power Wheelchair, D25 | power wheelchair, PL001 | / |
| 510(k) number | K241854 | K113463 | / |
| Device classification name | Class II | Class II | Same |
| Classification regulations | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | Same |
| Similarities | |||
| 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. | They are 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. | Same |
| Intended | disabled or elderly person | disabled or elderly person | Same |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| user | limited to a seated position | limited to a seated position | |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 4, including two front wheels and two rear wheels | 4, including two pivoting casters and two rear drive wheels | Same |
| Function of wheels | Front wheels: driven wheels suitable for rotation, acceleration, retrograde | ||
| Rear wheels: driving wheels to control the speed and direction | two pivoting casters: driven wheels suitable for rotation, acceleration, retrograde | ||
| two rear drive wheels: driving wheels to control the speed and direction | Same | ||
| Movement control method | By Joystick control | By Joystick control | Same |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Brake system | Intelligent electromagnetic brake system | Intelligent regenerative Electromagnetic brake | Same |
| Max speed forward | Up to 6 km/h (3.75 mph), continuously adjustable | Up to 6 km/h (3.75 mph), variable | Same |
| Maximum distance of travel on the fully charged battery | 20 km | 20 km | Same |
| Main frame material | aluminum alloy, front and rear folding | aluminum alloy, front and rear folding | Same |
| Armrest cushion | Polyurethane (PU) | PU | Same |
| Differences | |||
| Overall dimensions (LxWxH) | 1030 × 610 × 1010 mm | 880 mm×570 mm×890 mm | larger size is designed for bearing more loading weight. All safety and performance have been validated with the maximum rated weight dummy. |
| Folded dimensions (LxWxH) | 610 × 380 × 840 mm | 720 mm×570 mm×400 mm | safety and performance have been validated with the maximum rated weight dummy. |
| Ground clearance | 120 mm | 80 mm | larger ground clearance provides |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| Front wheel size/type | 7.9"x2" /PU Solid tire | 6"x 2"/PU Solid tire | larger size of driven wheel will provide better safety performance. |
| Rear wheel size/type | 12.4"×2.4" /PU Solid tire | 8" x 2.4"/PU Solid tire | better stability and safety performance |
| Battery | li-ion battery pack; rechargeable, 24 VDC 11.6Ah | Li-ion, Rechargeable; 24 VDC 20Ah | Same rated voltage with different power capacity will not affect the safety and performance of the subject device. |
| Max Speed backward | 0.8 m/s (2.88km/h) | 2.4 mph (3.84 km/h) | minor difference on max. backward speed will not cause different performance. lower speed will be more safety. |
| Minimum braking distance from maximum speed | Forward: 0.9 m | Forward:1.5 m (59") | subject device has shorter braking distance than the predicate device, such differences will not affect safety and performance of the device. |
| Minimum braking time from maximum speed | 0.6 second | Not available | The minimum braking time for our device is 0.6 second, which will ensure the device can be stopped on time as required, and such differences will not affect safety and performance of the device. |
| Max loading weight | 120kg (264 lbs) | 114 kg (251 lbs) | minor difference on loading weight will not cause different performance. more loading weight provide more convenient and stable performance for |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| Maximum | |||
| safe | |||
| operational | |||
| incline | |||
| degree | 8 ° | 9 ° | minor difference on |
| safe operational | |||
| incline degree will not | |||
| cause new safety and | |||
| effectiveness | |||
| concerns. Both the | |||
| static and dynamic | |||
| stability under specific | |||
| inclining degree have | |||
| been evaluated | |||
| according to standard | |||
| ISO 7176 series. | |||
| Battery | |||
| charger | Off-board charger | ||
| Input: 100-240V, 50/60Hz, | |||
| 1.5A | |||
| Output: 24 Vdc, 2A | Off-board, Automatic | ||
| Type | |||
| Input: 110-220 V / 50-60 | |||
| Hz, | |||
| Output: 24 Vdc, 2A; | More wide range of | ||
| input voltage in the | |||
| device which will not | |||
| cause new safety and | |||
| effectiveness | |||
| concerns raised. | |||
| Motor | Brush motor; 24VDC; | ||
| 200W; 2pcs | Brushless DC motor; 24 | ||
| VDC; 180 W; 2 pcs | minor difference on | ||
| motor power will not | |||
| cause different | |||
| performance. larger | |||
| power will provide | |||
| more driving force, no | |||
| safety and | |||
| effectiveness | |||
| concerns raised. | |||
| Electronic | |||
| controller | brush power wheelchair | ||
| controller | Brushless dual-drive | ||
| rocker controller | Both of the control | ||
| systems are evaluated | |||
| according to standard | |||
| ISO 7176-14 and | |||
| software validation | |||
| requirement and there | |||
| are no new safety and | |||
| effectiveness | |||
| concerns due to the | |||
| difference. | |||
| Turning | |||
| Radius | 650 mm (25.5") | 31.5" (800 mm) | The minor difference |
| in the turning radius | |||
| will not raise any new | |||
| safety and | |||
| effectiveness | |||
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| Maximum obstacle climbing | 20 mm | 1.2" (30 mm) | Minor difference in the obstacle climbing will not impact the safety and effectiveness of the subject device. |
| seat cushion | Sponge foam covered Denim fabric | PU foam covered by nylon fabric cloth | different material used for parts in contact |
| back cushion | Sponge foam covered Denim fabric | PU foam covered by nylon fabric cloth | with user, which such differences will not impact the safety and effectiveness of the subject device as biocompatibility tests are carried out according to ISO 10993 series. |
VI. Comparison of technological characteristics with the predicate device
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VII. Summary of substantial equivalence discussion
The power wheelchair complied with the requirements of 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, ISO10993-5:2009, ISO 10993-10:2021, ISO 10993-23: 2021, IEC60601-1-2: 2020.
The indications for use for both devices are the same. Mainframes of two devices are and the frame materials are the same aluminum alloy. The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14. Software validation is carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3. Turning radius, Maximum obstacle climbing and Maximum safe operational incline are slightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-2 and ISO 7176-10. The biocompatibility of the subject device is evaluated according to
10
standard ISO 10993-1 and meet the requirements accordingly.
The flame-retardant test of the seat cushion/ backrest of both subject device and predicate device is carried out according to the ISO 16840-10 test. Therefore, both devices are assured to be under the same safety level.
In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
VIII. Summary of non-clinical testing
A 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
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- . 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
- . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020.
A Biocompatibility of patient-contacting material
Biocompatibility Tests are 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). Details of the test summary see biocompatibility summary.
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 K113463.