(194 days)
Not Found
No
The device description details a standard power wheelchair controlled by a joystick, with no mention of AI or ML capabilities for navigation, control, or other functions. The performance studies focus on compliance with standard wheelchair safety and performance standards.
No
The device is a power wheelchair, a mobility aid for disabled or elderly individuals, not a device directly used to treat or cure a disease or condition.
No
The device is a power wheelchair, a transportation vehicle designed to provide mobility. Its intended use is to transport individuals who are limited to a seated position, not to diagnose medical conditions.
No
The device description clearly outlines numerous hardware components including a battery, motor, wheels, joystick controller, and a physical structure, indicating it is a physical device with integrated software for control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to a disabled or elderly person. This is a physical assistance device, not a diagnostic tool.
- Device Description: The description details the mechanical and electrical components of a power wheelchair, all related to transportation and mobility. There are no components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This power wheelchair does none of that.
The information provided consistently describes a medical device used for mobility, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The YH-E7007 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. This product is suitable for disabled people with mobility difficulties and elderly people.
Product codes
ITI
Device Description
The subject device, Power Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed.
The power wheelchair is a battery powered four wheeled vehicle. It consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel(including: Battery indicate, ON/OFF button, Horn, Gear indicator, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.
The operation of the scooter: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric/ manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The power wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.
The Power Wheelchair has 8 inch front wheel and 12 inch rear tire.
The motor of power wheelchair is DC24V 250W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/2A.
Max. loading can not be over than 120Kgs.
Max. distance of travel on the fully charged battery is 20km and Max. speed forward is 6km/h.
The braking time is about 2s, and the braking distance is ≤1.5m.
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- l ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- I ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
- I 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
- I ISO 7176-5 : 2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
- I ISO 7176-6: 2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- I 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 fatique strengths
- 트 ISO 7176-9: 2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- I ISO 7176-10 : 2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- 트 ISO 7176-11 : 2012 Wheelchairs - Part 11: Test dummies
- I ISO 7176-13 : 1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
- I ISO 7176-14 : 2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
- l ISO 7176-15: 1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- . ISO 7176-21: 2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- 트 ISO 7176-22 : 2014 Wheelchairs - Part 22: Set-up procedures
- ISO 7176-25 : 2014 Wheelchairs – Part 25: Batteries and chargers for powered wheelchairs
- l ISO 16840-10: 2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
- l IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
- . IEC 62133-1 Edition 1.0 2017-02: 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 - Part 1: Nickel systems
Biocompatibility of patient-contacting parts:
Patient-contacting material are carried out biocompatibility assessment in accordance with ISO 10993-1: 2018, including:
Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
Irritation and Skin Sensitization per ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Software Verification and Validation Testing:
Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern. The Software Validation is in compliance with FDA Guidance.
Summary of Clinical Testing:
No clinical study implemented for the electric wheelchair.
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 - USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top of the word "ADMINISTRATION".
September 16, 2024 Ningbo Youhuan Automation Technology Co., Ltd. % Boyle Wang Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai. 200120 China
Re: K240638
Trade/Device Name: Power Wheelchair (YH-E7007) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 21, 2024 Received: August 21, 2024
Dear Boyle 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
y require a new premarket notification are provided in the FDA
Page
2
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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Electric Wheelchair (YH-E7007)
Indications for Use (Describe)
It 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 K240638
Date of Preparation: February 4, 2024
Submitter's information
Name: Ningbo Youhuan Automation Technology Co.,Ltd. Address: Room 103-24, No. 352, No. 277 Shui Street, No. 756 Tiantong South Road, Yinzhou District, Ningbo City, Zhejiang Province, CN Tel: 86-13736172836 Contact: Francis Xu
Designated Submission Correspondent Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
Device information
Trade name: Power Wheelchair Common name: Power Wheelchair Classification name: Powered Wheelchair Model(s): YH-E7007
Classification
Production code: ודו Regulation number: 21 CFR 890.3860 Classification: Class II Panel: Physical Medicine
Predicate device information
JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. Manufacturer: Trade/Device: Y207 Electric Wheelchair 510(k) number: K202482
5
Indication for Use Statement
The YH-E7007 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. This product is suitable for disabled people with mobility difficulties and elderly people.
Device description
The subject device, Power Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed.
The power wheelchair is a battery powered four wheeled vehicle. It consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel(including: Battery indicate, ON/OFF button, Horn, Gear indicator, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.
The operation of the scooter: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric/ manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The power wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.
The Power Wheelchair has 8 inch front wheel and 12 inch rear tire.
The motor of power wheelchair is DC24V 250W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/2A.
Max. loading can not be over than 120Kgs.
Max. distance of travel on the fully charged battery is 20km and Max. speed forward is 6km/h.
The braking time is about 2s, and the braking distance is ≤1.5m.
Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- l ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- I ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of
6
- ' electrically powered wheelchairs
- I 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
- I ISO 7176-5 : 2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
- I ISO 7176-6: 2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- I 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 fatique strengths
- 트 ISO 7176-9: 2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- I ISO 7176-10 : 2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- 트 ISO 7176-11 : 2012 Wheelchairs - Part 11: Test dummies
- I ISO 7176-13 : 1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
- I ISO 7176-14 : 2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
- l ISO 7176-15: 1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- . ISO 7176-21: 2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- 트 ISO 7176-22 : 2014 Wheelchairs - Part 22: Set-up procedures
- ISO 7176-25 : 2014 Wheelchairs – Part 25: Batteries and chargers for powered wheelchairs
- l ISO 16840-10: 2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
- l IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
- . IEC 62133-1 Edition 1.0 2017-02: 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 - Part 1: Nickel systems
Biocompatibility of patient-contacting parts
Patient-contacting material are carried out biocompatibility assessment in accordance with ISO 10993-1: 2018, including:
Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
Irritation and Skin Sensitization per ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
7
Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern. The Software Validation is in compliance with FDA Guidance.
Summary of Clinical Testing
No clinical study implemented for the electric wheelchair.
Technological Characteristic Comparison Table
| Item | Proposed device | Predicate device | Remark |
|---|---|---|---|
| Product Code | ITI | ITI | Same |
| Regulation No. | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Class | II | II | Same |
| Product name | Power Wheelchair | Y207 Electric Wheelchair | - |
| 510(k) No. | Pending | K202482 | - |
| Models | YH-E7007 | Y207 | - |
| Intended Use | The YH-E7007 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. This product is suitable for disabled people with mobility difficulties and elderly people. | The Y207 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. This product is suitable for disabled people with mobility difficulties and elderly people. | Same |
| Use environment | Indoor and outdoor use | Indoor and outdoor use | Same |
| Patient Population | This product is suitable for disabled people with mobility difficulties and elderly people. | This product is suitable for disabled people with mobility difficulties and elderly people. | Same |
Table 1: General Comparison
8
| Product structure | Consist of two foldable armrests, a
backrest, a seat cushion, a safety
belt, a foldable frame, two rear driving wheels with hub
motor/electromagnetic brake
assemblies, two pivoting casters,
two Li-ion batteries, an off-board
battery charger, a control panel,
and an electric motor controller. | The device consists of two
parts: the electrical part and
the wheelchair main body.
The electrical part includes
motor, battery box, controller
and charger. The main parts
of the wheelchair include
front wheels, rear wheels,
frame, armrest, seat and
back upholstery. | Similar |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Number of
wheels | 4 | 4 | Same |
| Main frame
material | Aluminium alloy | Aluminium alloy | Same |
| Motor | Brushless motor,
DC24V* 250W*2pcs | Brushless motor,
24 VDC *200W * 2 pcs | Minor differences in the |
| Battery | DC 24V 12Ah Lithium-ion, 2 pcs | Lithium-ion
20 Ah x 24 VDC | dimensions will not
impact the safety and |
| Battery charger | Off-board charger
Input: 100-240 VAC
Output: DC 24V, 2A | Off-board charger
Input: 100-240 VAC
Output: DC 24V, 6 Amp | effectiveness of the
substantial equivalence. |
Table 2: Performance Comparison
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Dimensions | |||
| (mm) | 1080 x 610 x 960 | 1110 x 700 x 980 | Minor differences in the |
| dimensions will not | |||
| impact the safety and | |||
| effectiveness of the | |||
| substantial equivalence. | |||
| Folded | |||
| dimensions | |||
| (mm) | 810x610x410 | 810 x 700 x 400 | Minor differences in the |
| folded dimensions will not | |||
| impact the safety and | |||
| effectiveness of the | |||
| substantial equivalence. | |||
| Weight, w/ | |||
| Battery | 61.73 lbs. /28 kg | Not publicly available | The difference will |
| not raise any new safety | |||
| and effectiveness | |||
| concerns. | |||
| Frame design | Foldable/ | ||
| The device consists of a foldable | |||
| and non-rigid type of power | |||
| wheelchair base with rear drive and | |||
| 2 casters in the front and two | |||
| anti-tippers in the rear. | Foldable/ | ||
| The device consists of two | |||
| parts: the electrical part | |||
| and the wheelchair main | |||
| body. The electrical part | |||
| includes motor, battery | |||
| box, controller and | |||
| charger. The main parts of | |||
| the wheelchair include | |||
| front wheels, rear wheels, | |||
| frame, armrest, seat and | |||
| back upholstery. | Same | ||
| Folding | |||
| mechanism | A foldable seat frames | ||
| (The backrest could be folded to | |||
| seat) | Not publicly available | The folding mechanism of the | |
| predicate device is not | |||
| publicly available. No impact | |||
| on safety and effectiveness. | |||
| Front | |||
| wheel(inch) | 8 | ||
| (Solid tires) | 8 | ||
| (PU solid tire) | Same | ||
| Rear tire (inch) | 12 | ||
| (Pneumatic tire) | 10 | ||
| (PU solid tire) | Larger sizes of front wheels | ||
| bring steadier pivoting | |||
| function than predicate | |||
| device. | |||
| Cruising | |||
| Range(km) | 20 | 20 | Same |
| Obstacle | |||
| climbing(mm) | 25 | 50 | The smaller height in the |
| obstacle climbing will not | |||
| impact the safety and | |||
| effectiveness of the subject | |||
| device. | |||
| Static stability | |||
| forward | 27.1° | Not publicly available | Both of the devices are |
| evaluated according to | |||
| standard ISO 7176-1:2014, | |||
| so the different static stability | |||
| will not impact the safety | |||
| and effectiveness | |||
| Static stability | |||
| rearward | 19.9° | ||
| Static stability | |||
| sideways | 20.5° | ||
| Max. loading | |||
| (kg) | 264.5lbs(120kg) | 275lbs (125kg) | Less loading weight means |
| more convenient for the | |||
| transportation | |||
| Maximum safe | |||
| operational | |||
| incline | 9 degrees | 8 degrees | Larger safe operational |
| incline of subject bring more | |||
| convenient for the use | |||
| environment | |||
| Min. Turning | |||
| radium | 975mm | 950mm | The little difference in the |
| turning radius will bring more | |||
| convenience when it turns. | |||
| The difference will not raise | |||
| any new safety and | |||
| effectiveness concerns. | |||
| Minimum | |||
| braking | |||
| distance | 1.5m | 1.5m | Same |
| Max. Speed | |||
| Forwards | 1.7m/s (6 km/h) | 1.5m/s (5.4 km/h) | The devices are evaluated |
| according to standard ISO | |||
| 7176-6:2018, so the different | |||
| will not impact the safety | |||
| and effectiveness | |||
| Max. Speed | |||
| Backward | 1.0m/s (3.6 km/h) | 0.8m/s (2.88 km/h) | The devices are evaluated |
| according to standard ISO | |||
| 7176-6:2018, so the different | |||
| will not impact the safety | |||
| and effectiveness | |||
| Controller | Zhejiang Shiyou Driving Technology | ||
| Co., Ltd. | |||
| SYC-JCM21L | PG Drives Technology | ||
| Ltd., | |||
| newVSI | Different | ||
| Although different controller | |||
| is used, both the control | |||
| system, including the joystick | |||
| controller, the | |||
| electromagnetic brakes and | |||
| the user interface are similar. | |||
| The joystick controls the | |||
| directions and speed of | |||
| movement, and when the | |||
| joystick is released, the | |||
| powered wheelchair will slow | |||
| down to stop and the brakes | |||
| will automatically re-engage. | |||
| The controller also provides | |||
| the battery status displaying | |||
| and abnormal condition | |||
| displaying. Both of the control | |||
| systems are evaluated | |||
| according to standard ISO | |||
| 7176-14:2008 and software | |||
| validation requirement and | |||
| there are no new safety and | |||
| effectiveness concerns due | |||
| to the difference. | |||
| Speed control | |||
| method | joystick control method | joystick control method | Same |
9
10
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| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Materials | |||
| contacting user | Armrest: PU; | ||
| Backrest/Seat/Seat belt: Polyester | |||
| Controller Housing:ABS | |||
| Joystick: Silicone rubber | Armrest: PU; | ||
| Backrest/seat: sandwich mesh fabric (polyester) | |||
| newVSi electric wheelchair controller: | |||
| Joystick knob: Santoprene 101-80; | |||
| Joystick Gaiter: Silicone 3032 (50%) & 5031 (50%) | |||
| Enclosure Moulding(s): ABS/PC Wonderloy PC-540 | |||
| Keypad: Silicone keypad coatings TC-2407 & CH-6330 | Biocompatibility evaluation has been carried out per ISO 10993-1. | ||
| There are no new safety and effectiveness concerns due to the difference. | |||
| Biocompatibility | |||
| of materials | |||
| contacting user | Comply with ISO 10993-1, FDA Guidance | Comply with ISO 10993-1, FDA Guidance, Tests included | |
| Cytotoxicity (ISO 10993-5:2009), | |||
| Sensitization and Intracutaneous Reactivity (ISO 10993-10:2010) | Same |
Table 3: Safety Comparison
Summary of substantial equivalence discussion:
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. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device in K202482 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.