(169 days)
The device 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 subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs 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 NXN20-208 and NXN20-211 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position.
The Powered Wheelchair has 7 inch front wheel and 11 inch rear tire.
The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A.
Max. loading can not be over than 110Kgs.
Max. distance of travel on the fully charged battery is 16 km and Max. speed forward is 6km/h.
The braking time is about 2s, and the braking distance is <=1.77m.
The provided document is a 510(k) premarket notification for a Powered Wheelchair (models NXN20-208, NXN20-211). It focuses on demonstrating substantial equivalence to a predicate device (A08 Power Wheelchair, K163204) rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding clinical studies, ground truth establishment, expert adjudication, and AI performance is not applicable to this submission.
However, the document does contain "acceptance criteria" through a demonstration of compliance with recognized standards and a comparison of performance characteristics to a predicate device, which serves as a benchmark for safety and effectiveness in this regulatory context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (Standard Compliance) and Reported Device Performance
For a medical device like a powered wheelchair, acceptance criteria are generally defined by compliance with a set of established performance standards. The "reported device performance" is demonstrated by the completion of non-clinical tests verifying compliance with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance Status) |
|---|---|
| ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability | Complies |
| ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs | Complies |
| ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes | Complies |
| ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Complies |
| ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space | Complies |
| ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Complies |
| ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions | Complies |
| ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strengths | Complies |
| ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs | Complies |
| ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | Complies |
| ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies | Complies |
| ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces | Complies |
| ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | Complies |
| ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling | Complies |
| ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers | Complies |
| ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures | Complies |
| ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs | Complies |
| ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method | Complies |
| IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | Complies |
| Software Verification and Validation Testing (according to FDA Guidance) | Complies |
| Biocompatibility of materials contacting user (Comply with FDA Guidance) | Complies |
Performance Characteristics (Comparison with Predicate Device):
| Item | Proposed Device | Predicate Device | Acceptance (Remark) |
|---|---|---|---|
| Overall length | NXN20-208: 1000mm; NXN20-211: 950mm | 890 mm | Minor differences will not impact safety and effectiveness. |
| Overall width | 600mm | 603 mm | Minor differences will not impact safety and effectiveness. |
| Stowage length | 340mm | 324 mm | Minor differences will not impact safety and effectiveness. |
| Stowage width | 600mm | 603 mm | Minor differences will not impact safety and effectiveness. |
| Stowage height | NXN20-208: 775mm; NXN20-211: 765mm | 670 mm | Minor differences will not impact safety and effectiveness. |
| Weight, w/ Battery | NXN20-208: 42.99 lbs./19.5kg; NXN20-211: 36.48 lbs./16.55kg | 61.7 lbs. /28 kg | The difference will not raise any new safety and effectiveness concerns. |
| Front wheel (inch) | 7 (PU solid tire) | 8 (PU solid tire) | Smaller sizes of front wheels. |
| Rear tire (inch) | 11 (PU solid tire) | 10 (PU solid tire) | Larger sizes of rear wheels bring steadier pivoting function than the predicate device. |
| Cruising Range (km) | 16 | 20 | The subject device complies with ISO 7176-4:2008 for energy consumption; these differences do not affect safety and effectiveness. |
| Obstacle climbing (mm) | 25 | 40 | The smaller height in the obstacle climbing will not impact the safety and effectiveness of the subject device. |
| Static stability forward | 18.8° | Not publicly available | Both devices evaluated per ISO 7176-1:2014; different static stability will not impact safety and effectiveness. |
| Static stability rearward | 20.4° | Not publicly available | Both devices evaluated per ISO 7176-1:2014; different static stability will not impact safety and effectiveness. |
| Static stability sideways | 20.5° | Not publicly available | Both devices evaluated per ISO 7176-1:2014; different static stability will not impact safety and effectiveness. |
| Max. loading (kg) | 242.5lbs (110kg) | 220 lbs (100 kg) | More loading weight means more convenient for transportation. |
| Min. Turning radium | NXN20-208: 850mm; NXN20-211: 840mm | 800mm | Similar |
| Minimum braking distance | <=1.77m | 1m | Similar |
| Max Speed Forwards | 1.66 m/s (6 km/h) | 1.94 m/s (7 km/h) | Devices evaluated per ISO 7176-6:2018; the difference will not impact safety and effectiveness. |
| Max. Speed Backward | 0.8 m/s (2.88 km/h) | Not publicly available | Devices evaluated per ISO 7176-6:2018; the difference will not impact safety and effectiveness. |
| Controller | Yanteon Mechanical & Electronic Technology (Shanghai) Co. Ltd. Joystick Y2450M Controller Y2430M | Yisheng Electric Co. Ltd. WS-1, 40A | Although different controllers are used, both control systems are similar and evaluated according to ISO 7176-14:2008 and software validation requirements; no new safety and effectiveness concerns. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as this is a device clearance based on standard compliance and comparison, not an image-based AI study with a "test set" in that context. The tests were performed on the physical device models NXN20-208 and NXN20-211.
- Data Provenance: The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications." These tests would have been conducted by the manufacturer (Zhejiang Nysin Medical Co., Ltd.) in China or by a contracted testing facility. The specific location and retrospective/prospective nature of the individual test data are not detailed, but it is implied to be new test data generated for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For a powered wheelchair, "ground truth" is typically established through objective measurements and testing against engineering and safety standards, rather than expert consensus on medical images or patient diagnoses.
- Qualifications of Experts: Not applicable for the reasons above. Testing would be performed by qualified engineers and technicians.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. The "test set" here refers to physical device testing against established standards, not a diagnostic task requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this is not an AI-based diagnostic device. It is a powered wheelchair. Therefore, no MRMC study was conducted, and this question is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this device is based on objective, quantifiable measurements against internationally recognized performance and safety standards (e.g., ISO 7176 series, IEC 60601-1-2) and visual inspections of the device. For biocompatibility, it's compliance with FDA guidance and ISO 10993-1.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. There is no training set for this device.
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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 consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
November 20, 2024
Zhejiang Nysin Medical Co., Ltd. % Boyle Wang Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai. 200120 China
Re: K241603
Trade/Device Name: Powered Wheelchair (NXN20-208, NXN20-211) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: October 21, 2024 Received: October 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.
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"
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(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).
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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
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Indications for Use
Submission Number (if known)
Device Name
Powered Wheelchair (NXN20-208, NXN20-211)
Indications for Use (Describe)
The device 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)
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510(k) Summary
K241603
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's information
Name: Zhejiang Nysin Medical Co., Ltd. Address: Building 13, No. 305 Jiulong North Road, Dongcheng District, Yongkang, Jinhua City, Zhejiang Province, China Tel: +86-579-87153722/ +86-18969388822 Contact: Zhang Xiaoying
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
Date of Preparation: Mar.28, 2024
2.0 Device information
Trade name: Powered Wheelchair Common name: Powered Wheelchair Classification name: Powered Wheelchair Model(s): NXN20-208, NXN20-211
3.0 Classification
Production code: ITI Regulation number: 21 CFR 890.3860 Classification: Class II Panel: Physical Medicine
4.0 Predicate device information
Manufacturer: Kunshan Aoshida Electric Technology Co., Ltd. Trade/Device: A08 Power Wheelchair
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510(k) number: K163204
5.0 Indication for Use Statement
The device 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.
6.0 Device description
The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs 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 NXN20-208 and NXN20-211 Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position.
The Powered Wheelchair has 7 inch front wheel and 11 inch rear tire.
The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A.
Max. loading can not be over than 110Kgs.
Max. distance of travel on the fully charged battery is 16 km and Max. speed forward is 6km/h.
The braking time is about 2s, and the braking distance is ≤1.77m.
7.0 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:
ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed,
acceleration and deceleration of electric wheelchairs
ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
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ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strengths
ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies
ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Content of Premarket Submissions for Device Software Functions for software.
The Software Validation is in compliance with FDA Guidance.
8.0 Summary of Clinical Testing .
No clinical study implemented for the electric wheelchair.
9.0 Technological Characteristic Comparison Table
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| 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 | Powered Wheelchair | A08 Power Wheelchair | - |
| 510(k) No. | K241603 | K163204 | - |
| Models | NXN20-208NXN20-211 | A08 | - |
| Intended Use | The device is a motor driven,indoor and outdoortransportation vehicle with theintended use to providemobility to a disabled orelderly person limited to aseated position. | It is a motor driven, indoor andoutdoor transportation vehiclewith the intended use toprovide mobility to a disabledor elderly person limited to aseated position. | Same |
| Use environment | Indoor and outdoor use | Indoor and outdoor use | Same |
| PatientPopulation | This product is suitable fordisabled people with mobilitydifficulties and elderly people. | This product is suitable fordisabled people with mobilitydifficulties and elderly people. | Same |
| Product structure | Consist of two foldablearmrests, a backrest, a seatcushion, a safety belt, afoldable frame, two reardriving wheels with hubmotor/electromagnetic brakeassemblies, two pivotingcasters, two Li-ion batteries,an off-board battery charger, acontrol panel, and an electricmotor controller. | Consists primarily of afoldable welded-aluminumframes, two sealed transaxlemotors drive system,electromagnetic brakingsystem, electric motorcontroller and two Li-ionbatteries with an off-boardbattery charger. | Similar |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Movement controlmethod | By Joystick control | By Joystick control | Same |
| Number ofwheels | 4 | 4 | Same |
| Brake system | Automatic electromagneticbrake system | Electromagneticbrake system | Same |
| Main framematerial | Model NXN20-208 consists ofAluminum alloy, and modelNXN20-211 consist withAluminum alloy+Carbon fiber. | Welded-aluminum | DifferentThe differences in themain frame material willnot impact the safety andeffectiveness of thesubstantial equivalence. |
| Motor | Brushless motor,DC24V* 200W*2pcs | Brushless motor,24 VDC *250W * 2 pcs | Minor differences in thedimensions will notimpact the safety andeffectiveness of thesubstantial equivalence. |
| Battery | DC 24V 12Ah Lithium-ion,2 pcs | Lithium-ion20 Ah x 24 VDC | |
| Battery charger | Off-board chargerInput: 100-240 VACOutput: DC 24V, 3A | Off-board chargerInput: 110-240 VACOutput: DC 24V, 2 Amp |
Table1-General Comparison
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Table2 Performance Comparison
| Item | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Model | NXN20-208 | NXN20-211 | A08 | -- |
| Overall length | 1000mm | 950mm | 890 mm | |
| Overall width | 600mm | 600mm | 603 mm | Minor differences inthe dimensions willnot impact the safetyand effectiveness ofthe substantialequivalence. |
| Stowagelength | 340mm | 340mm | 324 mm | |
| Stowagewidth | 600mm | 600mm | 603 mm | |
| Stowageheight | 775mm | 765mm | 670 mm | |
| Weight, w/Battery | 42.99 lbs./19.5kg | 36.48 lbs./16.55kg | 61.7 lbs. /28 kg | The difference willnot raise any newsafety andeffectivenessconcerns. |
| Front wheel(inch) | 7(PU solid tire) | 8(PU solid tire) | Smaller sizes of fontwheels | |
| Rear tire(inch) | 11(PU solid tire) | 10(PU solid tire) | Larger sizes of rearwheels bring steadierpivoting function thanpredicate device. | |
| CruisingRange(km) | 16 | 20 | The subject devicecomplies with ISO7176-4: 2008Wheelchairs - Part 4:Energy consumptionof electricwheelchairs andscooters fordetermination oftheoretical distance | |
| Obstacleclimbing(mm) | 25 | 40 | range, thesedifferences do notaffect safety andeffectiveness.The smaller height inthe obstacle climbingwill not impact thesafety andeffectiveness of thesubject device. | |
| Static stabilityforward | 18.8° | Not publicly available | Both of the devicesare evaluatedaccording tostandard ISO7176-1:2014, so thedifferent staticstability will notimpact the safety andeffectiveness | |
| Static stabilityrearward | 20.4° | |||
| Static stabilitysideways | 20.5° | |||
| Max. loading(kg) | 242.5lbs(110kg) | 220 lbs (100 kg) | More loading weightmeans moreconvenient for thetransportation | |
| Min. Turningradium | 850mm | 840mm | 800mm | Similar |
| Minimumbrakingdistance | <=1.77m | 1m | Similar | |
| Max SpeedForwards | 1.66 m/s (6 km/h) | 1.94 m/s (7 km/h) | The devices areevaluated accordingto standard ISO7176-6:2018, so thedifferent will notimpact the safety andeffectiveness | |
| Max. SpeedBackward | 0.8 m/s (2.88 km/h) | Not publicly available | The devices areevaluated accordingto standard ISO7176-6:2018, so thedifferent will notimpact the safety andeffectiveness | |
| Controller | Yanteon Mechanical &Electronic Technology | Yisheng Electric Co.Ltd | DifferentAlthough different | |
| Speed controlmethod | (Shanghai) Co. Ltd.Joystick Y2450MController Y2430M | WS-1, 40A | controller is used,both the controlsystem, including thejoystick controller,the electromagneticbrakes and the userinterface are similar.The joystick controlsthe directions andspeed of movement,and when the joystickis released, thepowered wheelchairwill slow down tostop and the brakeswill automaticallyre-engage. Thecontroller alsoprovides the batterystatus displaying andabnormal conditiondisplaying. Both ofthe control systemsare evaluatedaccording tostandard ISO7176-14:2008 andsoftware validationrequirement andthere are no newsafety andeffectivenessconcerns due to thedifference. | |
| Joystick control method | Joystick control method | Same |
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Table3 Safety Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Materialscontacting user | Armrest: PU; | Armrest: PU; | Biocompatibility evaluationhas been carried out per |
| Backrest/Seat/Seat belt: | Backrest/seat cushion: PU foamcovered by nylon fabric cloth | ISO 10993-1. There are nonew safety and | |
| Sandwich mesh fabric(polyester) | effectiveness concerns due | ||
| Safety Belt: Nylon |
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| Controller Housing: ABSJoystick/button: SiliconeFootplates: ABS | to the difference. | ||
|---|---|---|---|
| Biocompatibilityof materialscontacting user | Comply with FDA Guidance | Comply with ISO 10993-1, FDAGuidance, Tests includedCytotoxicity (ISO 10993-5:2009),Sensitization and IntracutaneousReactivity (ISO 10993-10:2010) | Same |
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.
10.0 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 under K163204.
§ 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).