(218 days)
Not Found
No
The device description and performance studies focus on basic mechanical and electrical controls (joystick, electromagnetic brake) and standard wheelchair performance and safety testing. There is no mention of AI/ML terms, image processing, or data sets for training/testing.
No.
The device's sole intended use is to provide mobility. It does not treat or cure any medical condition.
No.
A diagnostic device is used to diagnose a condition, disease, or injury. The electric wheelchair is described as a transportation vehicle to provide mobility, not to diagnose any condition.
No
The device description clearly outlines numerous hardware components including a frame, wheels, motors, batteries, joystick, and control panel. While it includes software validation, it is not solely software.
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, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing information about a person's health status through such analysis.
- Performance Studies: The performance studies focus on the physical and electrical performance of the wheelchair, not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This electric wheelchair does not fit that definition.
N/A
Intended Use / Indications for Use
The Electric 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. It is suitable for disabled people with mobility difficulties and elderly people.
Product codes
ITI
Device Description
The Electric wheelchair, YE200, is a powered wheelchair that is designed to fold when not in use so it can be more easily transported in a car trunk or similar space. It uses rechargeable lithium batteries, and is controlled by a joystick and a few other simple controls which are located on the end of the armrest. The joystick assembly may be installed on either side of the chair to accommodate both right-handed and left-handed users.
The Electric wheelchair consists of two armrests, a back rest, a seat cushion, a foldable frame, two rear drive wheels with hub motor and electromagnetic brake assemblies, two pivoting casters, two Li-ion battery pack, an off-board battery charger, a control panel (joystick) with connect cables and an electric motor controller. The device is powered by Li-ion battery pack, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet when the device is not in use.
The user can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
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 people and elderly people / 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)
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 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020.
Biocompatibility of patient-contacting material: Biocompatibility Tests are carried out in accordance with ISO10993-1: 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.
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.
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 shows 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 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.
January 11, 2025
Shenzhen Yattll Industry Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K241641
Trade/Device Name: Electric Wheelchair (YE200) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 12, 2024 Received: December 12, 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.
1
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 (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 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 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-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,
Heather L. Dean -S
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
Submission Number (if known)
Device Name
Electric Wheelchair (YE200)
Indications for Use (Describe)
The Electric 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
K241641
l. SUBMITTER
Name: SHENZHEN YATTLL INDUSTRY CO., LTD
Address: Room 907, A&I International Center, No. 8 Gaoerfu blvd, Longhua Dist, Shenzhen
City, Guangdong Province, China
Name of contact person: Kevin Shih
Telephone: +86-13712089970
Email: yattll06@yattll.com
Date prepared: 2024-12-12
II. Device
Device trade name: Electric Wheelchair
Model: YE200
Classification name: Powered wheelchair
Regulation class: 2
Regulation number: 21CFR 890.3860
Panel: Physical Medicine
Product code: ITI
III. Predicate device
Electric Wheelchair, DC01
Anhui JBH Medical Apparatus Co., Ltd.
IV. Device description
The Electric wheelchair, YE200, is a powered wheelchair that is designed to fold when not in use so it can be more easily transported in a car trunk or similar space. It uses rechargeable lithium batteries, and is controlled by a joystick and a few other simple controls which are located on the end of the armrest. The joystick assembly may be installed on either side of the chair to accommodate both right-handed and left-handed users.
5
The Electric wheelchair consists of two armrests, a back rest, a seat cushion, a foldable frame, two rear drive wheels with hub motor and electromagnetic brake assemblies, two pivoting casters, two Li-ion battery pack, an off-board battery charger, a control panel (joystick) with connect cables and an electric motor controller. The device is powered by Li-ion battery pack, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet when the device is not in use.
The user can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
V. Indication for use
The Electric 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. It is suitable for disabled people with mobility difficulties and elderly people.
| Attribute | Predicate device | Subject device | Discussion/
Conclusion |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary
name | Electric wheelchair | Electric wheelchair | / |
| Model | DC01 | YE200 | / |
| 510(k)
number | K212092 | K241641 | / |
| 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 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 Electric 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. | Same |
| Attribute | Predicate device | Subject device | Discussion/Conclusion |
| Intended user | disabled people and elderly people | disabled people and elderly people | Same |
| 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 front casters: driven wheels suitable for rotation, acceleration, retrograde
two rear wheels: driving wheels to control the speed and direction | Same |
| Folding mechanism | front and rear folding | front and rear folding | 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 | Smart Electromagnetic brake | Automatic electromagnetic brake | Same |
| Electronic controller | Dual Drive Controller for Brushless | Dual Drive Controller for Brushless | Same |
| Motor | Brushless DC motor 180W x 24 VDC x 2 pcs | Brushless DC motor; 24 VDC; 180 W; 2 pcs | Same |
| Max loading weight | 120 kg (264 lbs) | 120 kg (264 lbs) | Same |
| Armrest | PU (polyurethane) | PU (polyurethane) | Same |
| Differences
Frame design and material | 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 main frame is made of carbon fiber material. | The frame of the wheelchair is type of aluminum frame with front and rear folding structure and flip-up armrest. The main frame is made of Aluminum alloy material. | Although the different frame material used on the subject device compared to the predicate device, while all safety and performance tests are conducted on the subject device and all passed. Such difference will not affect the safety and performance of the subject device. |
| Attribute | Predicate device | Subject device | Discussion/
Conclusion |
| Overall
dimensions
(LxWxH) | 1110 mm x 700 mm x 980 mm | 1107mmX620mmX950mm | Minor difference on wheelchair
dimensions will not cause different
performance. All safety and
performance have been validated with
the maximum rated weight dummy. |
| Folded
dimensions
(LxWxH) | 810 mm x 700 mm x 400 mm | 420mmX620mmX800mm | |
| Ground
clearance | 160 mm | 100mm | Minor difference on ground clearance
will not impact the safety and
effectiveness of the subject device. |
| Front wheel
size/type | 182mm45mm (7" x 1.75") /PU
Solid tire | 182mm55mm (7" x 2.1")/PU Solid tire | Minor difference on dimension of
wheels will not cause different
performance. |
| Rear wheel
size/type | 203mm50mm (8"x1.95") /PU
solid tires | 350mm61mm (13.7" x 2.4")/PU solid tire | |
| Max speed
forward | 6 km/h | 5.7km/h | Minor difference on max. forwarding
speed will not cause different
performance. |
| Minimum
braking
distance
from
maximum
speed | Forward: 0.5m | Forward: 0.75 m | Minor difference on braking distance
between subject device and
predicate device, while all relevant
tests are performed according to ISO
7176-3, no safety and effectiveness
concerns will be affected. |
| Maximum
safe
operational
incline
degree | 8 ° | 6 ° | Minor difference on safe operational
incline degree will not cause new
safety and effectiveness concerns are
raised as 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 charger
Input: 100-240V, 50/60Hz,
1.1A,
Output: 24 Vdc, 2A; | Minor input current difference will not
cause new safety and effectiveness
concerns raised. |
| Battery | Lithium-ion, 24V6Ah, 6Ah x 24
VDC | Li-ion battery, Rechargeable;
24 VDC 7.8Ah*2 | Same rated voltage, minor difference
on battery capacity will not cause
different performance. This difference
will not raise any new safety and
effectiveness concerns. |
| Attribute | Predicate device | Subject device | Discussion/Conclusion |
| Maximum distance of travel on the fully charged battery | 20 km | 16 km | Minor difference on travel distance will not cause different performance. This difference will not raise any new safety and effectiveness concerns. |
| Turning Radius | 800 mm | 875 mm | The minor difference in the turning radius is caused by different size of wheelchair and may cause a little bit inconvenience when it turns in a narrow space while the minor difference will not raise any new safety and effectiveness concerns. |
| Maximum obstacle climbing | 20 mm | 15 mm | Minor difference in the obstacle climbing will not impact the safety and effectiveness of the subject device. |
| back and sea cushion | linen cloth filled with PU foam | Polyester Mesh fabric filled with sponge | Different material used for parts in contact 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
6
7
8
VII. Summary of substantial equivalence discussion
The subject electric 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 7176-11:2008, ISO 7176-13:1989, ISO 7176-14:2008, 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, IEC 60601-1-2: 2020.
The intended uses for both devices are the same. Both mainframes of the two devices are folded by way of front and rear close. As for different frame materials used and minor difference on safe operational incline degree for both devices, considering all safety and performance tests are carried out on the subject device with favorable result, such difference will not affect the safety and performance of the subject device. The design principles of the
9
controller and Driving system are the same, and both meet the requirements of the ISO 7176-14:2008. 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 7176-3:2012. Turning radius, Maximum obstacle climbing and ground clearance 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 7176-2:2017, ISO 7176-10:2008.
The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2021 & ISO 10993-23: 2021.
All seat cushion/back cushion and armrest are made of flame retardant material for both devices. 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
> 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
10
- . 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 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
- . 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 ISO10993-1: 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
11
device.
Conclusions x.
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.