(176 days)
Not Found
No
The description details a standard powered wheelchair with a joystick control and electric motor. There is no mention of AI, ML, or any features that would suggest autonomous navigation, object detection, or adaptive control based on learned patterns. The software validation mentioned is for standard device software functions, not AI/ML.
No
The device is a transportation vehicle designed to provide mobility for disabled or elderly individuals, not to treat or cure a medical condition.
No
The device description indicates it is a powered wheelchair intended for mobility, not for diagnosing medical conditions.
No
The device description clearly outlines numerous hardware components including a motor, batteries, frame, wheels, and a control panel, indicating it is a physical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided description clearly states the device is a "motor driven, indoor and outdoor transportation vehicle" intended to "provide mobility to a disabled or elderly person limited to a seated position." This is a device for physical assistance and mobility, not for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to sample collection, analysis, reagents, or diagnostic testing.
Therefore, based on the provided information, this powered wheelchair is a mobility aid and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ITI
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 NXN20-209 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 12 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 16.5 km and Max. speed forward is 6km/h.
The braking time is about 2s, and the braking distance is ≤1.76m.
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
Indoor and outdoor use
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:
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
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.
No clinical study implemented for the electric wheelchair.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
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 22, 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: K241529
Trade/Device Name: Powered Wheelchair (NXN20-209) 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.
1
ion, or data verification, provided by 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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Powered Wheelchair (NXN20-209)
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)
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
K241529 - 510(k) Summary
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): NXN20-209
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 510(k) number: K163204
5
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 NXN20-209 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 12 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 16.5 km and Max. speed forward is 6km/h.
The braking time is about 2s, and the braking distance is ≤1.76m.
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
ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strengths
6
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
7
| 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. | K241529 | K163204 | - |
| Models | NXN20-209 | A08 | - |
| Intended Use | 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. | 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. | 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 | ||
| 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. | Consists primarily of a | ||
| foldable welded-aluminum | |||
| frames, two sealed transaxle | |||
| motors drive system, | |||
| electromagnetic braking | |||
| system, electric motor | |||
| controller and two Li-ion | |||
| batteries with an off-board | |||
| battery charger. | Similar | ||
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Movement control | |||
| method | By Joystick control | By Joystick control | Same |
| Number of | |||
| wheels | 4 | 4 | Same |
| Brake system | Automatic electromagnetic | ||
| brake system | Electromagnetic | ||
| brake system | Same | ||
| Main frame | |||
| material | Carbon fiber | Welded-aluminum | Different |
| The differences in the | |||
| main frame material willot impact the safety and | |||
| effectiveness of the | |||
| substantial equivalence. | |||
| Motor | Brushless motor, | ||
| DC24V* 200W*2pcs | Brushless motor, | ||
| 24 VDC *250W * 2 pcs | Minor differences in the | ||
| dimensions will not | |||
| impact the safety and | |||
| effectiveness of the | |||
| substantial equivalence. | |||
| Battery | DC 24V 12Ah Lithium-ion, 2 | ||
| pcs | |||
| Battery charger | Off-board charger | ||
| Input: 100-240 VAC | |||
| Output: DC 24V, 3A |
Table1-General Comparison
8
Table2 Performance Comparison
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Model | NXN20-209 | A08 | -- |
| Overall length | 930mm | 890 mm | Minor differences in the |
| dimensions will not impact | |||
| the safety and effectiveness | |||
| of the substantial | |||
| equivalence. | |||
| Overall width | 585mm | 603 mm | |
| Stowage | |||
| length | 740mm | 324 mm | |
| Stowage width | 265mm | 603 mm | |
| Stowage | |||
| height | 720mm | 670 mm | |
| Weight, w/ | |||
| Battery | 30.3 lbs. /13.75 kg | 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 font wheels | ||
| Rear tire (inch) | 12 | ||
| (PU solid tire) | 10 | ||
| (PU solid tire) | Larger sizes of rear wheels | ||
| bring steadier pivoting | |||
| function than predicate | |||
| device. | |||
| Cruising | |||
| Range(km) | 16.5 | 20 | The subject device complies |
| with ISO 7176-4: 2008 | |||
| Wheelchairs - Part 4: Energy | |||
| consumption of electric | |||
| wheelchairs and scooters for | |||
| determination of theoretical | |||
| distance range, 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 | 18.9° | 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 | 18.2° | ||
| Static stability | |||
| sideways | 20.7° | ||
| Max. loading | |||
| (kg) | 242.5lbs(110kg) | 220 lbs (100 kg) | More loading weight means |
| more convenient for the | |||
| transportation | |||
| Min. Turning | |||
| radium | 870mm | 800mm | Same |
| Minimum | |||
| braking | |||
| distance | $≤$ 1.76m | 1m | Similar |
| Max Speed | |||
| Forwards | 1.66 m/s (6 km/h) | 1.94m/s (7 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 | 0.8 m/s (2.88 km/h) | Not publicly available | The devices are evaluated |
| according to standard ISO | |||
| 7176-6:2018, so the different | |||
| will not impact the safety | |||
| and effectiveness | |||
| Controller | Yanteon Mechanical & | ||
| Electronic Technology | |||
| (Shanghai) Co. Ltd. | |||
| Joystick Y2450M | |||
| Controller Y2430M | Yisheng Electric Co. Ltd , | ||
| WS-1, 40A | 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 | |||
| 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
Table3 Safety Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Materials | |||
| contacting user | Armrest: PU; | ||
| Backrest/Seat/Seat belt: | |||
| Sandwich mesh fabric | |||
| (polyester) | |||
| Safety Belt: Nylon | |||
| Controller Housing: ABS | |||
| Joystick/button: Silicone | |||
| Footplates: ABS | Armrest: PU; | ||
| Backrest/seat cushion: PU foam | |||
| covered by nylon fabric cloth | 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 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 |
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.