(87 days)
The Electrical Wheelchair (Model: 9000N) is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to the disabled, the elderly and the infirm for short-distance travel.
The proposed device, Electrical wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed.
The electrical wheelchair consists of two foldable armrests, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Lithium-ion battery, a battery charger, a controller and master module. .
Wheelchair frame: Foldable for easy storage and transportation.
Controller and Master module: control the forward, steering and speed adjustment of the electric wheelchair.
Battery: It was installed at the bottom of the wheelchair.
Rear wheel (Driving Wheel): equipped with motor and electric brake device.
Front wheel: Provide support to keep the wheelchair stable.
The battery of electrical wheelchair is Lithium-ion 24V, 11AH, and the charger is Input: 100-240VAC,50-60Hz, 1.2-0.5A, Output:DC24V,3A
The maximum weight limitation of the user is 100kg.
This product can be quickly folded, disassembled, and is easy to place in the trunk of a car or lift upstairs.
The wheelchair is made of high-quality aluminum alloy. The weight without battery is 23kg.
This product is an indoor wheelchair that can be driven indoors or on flat roads near buildings. In principle, it cannot be cross-country. It is not recommended to drive on grass, gravel roads, slopes greater than 12°, and motor vehicle lanes.
The provided text describes the acceptance criteria and the study conducted for the Silver Fox Corporation Limited's Electrical Wheelchair, Model: 9000N.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the electrical wheelchair are based on compliance with numerous ISO standards. The document outlines comparisons to a predicate device (JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD. Electric Wheelchair, K192739), demonstrating the subject device's performance relative to these standards.
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance (Subject Device: 9000N) | Predicate Device Performance (K192739, JRWD6010 / JRWD6012) | Verdict / Impact on Safety/Effectiveness |
|---|---|---|---|
| Static Stability (ISO 7176-1:2014) | Meets standard, no impact on safety/effectiveness. | ||
| Forward Static Stability | 18.2° | 21.8° | Different values, but both evaluated according to ISO 7176-1:2014, so no impact on safety/effectiveness. |
| Rearward Static Stability | 18.0° | 19° | Different values, but both evaluated according to ISO 7176-1:2014, so no impact on safety/effectiveness. |
| Sideways Static Stability | Left: 17.6°, Right: 16.6° | 19.2° | Different values, but both evaluated according to ISO 7176-1:2014, so no impact on safety/effectiveness. |
| Dynamic Stability (ISO 7176-2:2017) | Complies | Complies | Same; meets requirements of ISO 7176-2:2017. |
| Brake Effectiveness (ISO 7176-3:2012) | Complies | Complies | Same; meets requirements of ISO 7176-3:2012. |
| Minimum Braking Distance | ≤1m (flat), ≤1.6m (3° slope) | 1m | Similar. |
| Energy Consumption / Range (ISO 7176-4:2008) | Complies | Complies | Same; meets requirements of ISO 7176-4:2008. |
| Cruising Range | 15.5 km | 20 km | Shorter cruising range, but will not affect product function and safety. |
| Overall Dimensions (ISO 7176-5:2008) | Complies | Complies | Same; meets requirements of ISO 7176-5:2008. |
| Dimensions | 39.0"x24.0"x38.0" | 38.1"x24.0"x37.0" (JRWD6010), 39.3"x23.6"x37.0" (JRWD6012) | Similar. |
| Folded Dimensions | 26.0"x24.0"x16.0" | Not publicly available | -- |
| Seat Cushion size | 18.0"x18.0"x3.0" | Not publicly available | -- |
| Max Speed, Acceleration, Deceleration (ISO 7176-6:2018) | Complies | Complies | Same; meets requirements of ISO 7176-6:2018. |
| Max. Speed (Forward) | 4.5 km/h (2.46 mph) | 6 km/h (3.75 mph) | Smaller Max. speed, but will not affect product function and safety; both evaluated to ISO 7176-6:2018. |
| Max. Speed (Backward) | 2.52 km/h (1.57 mph) | 4.5 km/h (2.80 mph) | Different, but both evaluated to ISO 7176-6:2018, no impact on safety/effectiveness. |
| Seating and Wheel Dimensions (ISO 7176-7:1998) | Complies | Complies | Same; meets requirements of ISO 7176-7:1998. |
| Rear tire (inch) | 8" (PU solid tire) | 10" (JRWD6010, PU solid), 12" (JRWD6012, Pneumatic) | Smaller sizes, but difference will not raise new safety and effectiveness concerns. |
| Static, Impact, Fatigue Strengths (ISO 7176-8:2014) | Complies | Complies | Same; meets requirements of ISO 7176-8:2014. |
| Climatic Tests (ISO 7176-9:2009) | Complies | Complies | Same; meets requirements of ISO 7176-9:2009. |
| Obstacle-Climbing Ability (ISO 7176-10:2008) | Complies | Complies | Same; meets requirements of ISO 7176-10:2008. |
| Obstacle climbing | 25 mm | 50 mm | Lower obstacle climbing, but will not affect product function and safety; both evaluated to ISO 7176-10:2008. |
| Test Dummies (ISO 7176-11:2012) | Complies | Complies | Same; meets requirements of ISO 7176-11:2012. |
| Max. loading | 100 kg (220 lbs) | 100 kg (220 lbs) | Same. |
| Coefficient of Friction of Test Surfaces (ISO 7176-13:1989) | Complies | Complies | Same; meets requirements of ISO 7176-13:1989. |
| Power and Control Systems (ISO 7176-14:2008) | Complies | Complies | Same; meets requirements of ISO 7176-14:2008. Software validation also performed on both control systems. |
| Information Disclosure, Documentation, Labeling (ISO 7176-15:1996) | Complies | Complies | Same; meets requirements of ISO 7176-15:1996. |
| Resistance to Ignition of Postural Support Devices (ISO 7176-16:2012) | Complies (for seat cushion and armrest) | Complies | Same; meets FDA flame retardancy requirements. |
| Wheeled Mobility Devices for use as seats in Motor Vehicles (ISO 7176-19:2008) | Complies | Complies | Same; meets requirements of ISO 7176-19:2008. |
| Electromagnetic Compatibility (ISO 7176-21:2009 & IEC 60601-1-2:2014) | Complies | Complies | Same; meets requirements of both. |
| Biocompatibility (ISO 10993-1:2018, -5:2009, -10:2010) | Complies for all contact materials | Complies for all contact materials | Same; no new safety/effectiveness concerns due to material differences. |
| Maximum Safe Operational Incline | 10° | 10 degrees | Same. |
| Minimum Turning Radius | 950mm | 1820mm | Subject device has a smaller turning radius, which brings more convenience and does not raise new safety/effectiveness concerns. |
| Battery | Lithium-ion 24V, 11AH, 1pcs | DC 24V 20Ah Lithium-ion, 1 pcs | Subject device has a lower output current, but this will not affect the use of the product function and safety. |
| Battery Charger | Input:AC 100-240V, 50/60Hz, Output:DC24V, 3A max | High Power Technology Inc. HP0180WL2 Input: 100-240 VAC Output: DC 24V, 6 Amp | Subject device has a lower output current, but this will not affect the use of the product function and safety. |
| Label and Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements | Same. |
| Software Level of Concern | Moderate | Moderate | Same. |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that the device's safety and performance were evaluated by lab bench testing. This implies that physical samples of the wheelchair were tested against the various ISO standards. The specific "sample size" in terms of number of units is not explicitly stated, but it would typically involve one or a small number of units for such bench tests to demonstrate compliance with engineering standards.
The data provenance is China, as Guangdong Jianda Medical Technology Co., Ltd. (the petitioner's representative) is based in Guangzhou, China, and the manufacturer (Silver Fox Corporation Limited) is based in JiangMen City, GuangDong Province, China. The studies are prospective in nature, as they involve testing the actual device against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. For engineering and performance standards like ISO 7176 series and IEC 60601-1-2, "ground truth" is established by the specifications defined in the standards themselves and the objective measurements obtained through test procedures. It does not typically involve expert consensus comparable to medical image analysis.
4. Adjudication Method for the Test Set
N/A. As mentioned above, the evaluation relies on objective measurements against defined standard criteria, not on expert adjudication of subjective assessments.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electrical wheelchair to its predicate device." Therefore, no MRMC study or comparative effectiveness study involving human readers or AI assistance was performed.
6. Standalone (Algorithm Only) Performance Study
N/A. This is a physical medical device (electric wheelchair), not an AI algorithm. Its performance is measured through physical bench testing against engineering standards.
7. Type of Ground Truth Used
The ground truth used is based on established engineering standards and specifications (e.g., ISO 7176 series, IEC 60601-1-2, ISO 10993 series). Device performance is compared directly against the quantitative and qualitative requirements set forth in these standards.
8. Sample Size for the Training Set
N/A. This device does not use an AI algorithm that requires a training set. The testing performed is non-clinical bench testing of a physical product.
9. How the Ground Truth for the Training Set Was Established
N/A. No training set or associated ground truth was established for this device as it is not an AI/software-driven diagnostic or therapeutic tool that relies on machine learning.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 16, 2022
Silver Fox Corporation Limited % Iris Fung Regulation Manager Guangdong Jianda Medical Technology Co., Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou. 510000 China
Re: K221799
Trade/Device Name: Electric Wheelchair, Model: 9000N Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 13, 2022 Received: June 21, 2022
Dear Iris Fung:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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).
Sincerely,
Tushar Bansal, Ph.D Acting 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
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Indications for Use
510(k) Number (if known) K221799
Device Name Electrical Wheelchair, Model: 9000N
Indications for Use (Describe)
The Electrical Wheelchair (Model: 9000N) is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to the disabled, the elderly and the infirm for short-distance travel.
| 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1. Submitter Information
Sponsor Company Name: Silver Fox Corporation Limited Address: No.18, 1st TongLe Road, TongLe Industrial Zone, TangXa Town, PengJiang District, JiangMen City, GuangDong Province, China. Phone: +86-13422526650 Contact Person (including title): CHEN YAN /QA manager E-mail: Yan.chen@silverfox.cn
Application Correspondent: Guangdong Jianda Medical Technology Co Ltd. Address: 906 Room, Longxiang Garden, Tianhe district, Guangzhou, China Contact Person:Ms. Iris Fung Tile: Regulation Manager Tel: +86- 13211147965 Email: mdc-fs@foxmail.com; jianda-lee@foxmail.com
2. Subject Device Information
Type of 510(k) submission: Traditional Common Name: Powered Wheelchair Trade Name: Electrical Wheelchair Classification Name: Powered Wheelchair Review Panel: Physical Medicine Product Code: ITI Regulation Number: 21 CFR 890.3860 Regulation Class: Class II
3. Predicate Device Information
Sponsor: JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD. Common Name: Powered Wheelchair Trade Name: Electric Wheelchair
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510(k) number: K192739 Review Panel: Physical Medicine Product Code: ITI Regulation Number: 21 CFR 890.3860 Regulation Class: Class II
4. Device Description
The proposed device, Electrical wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed.
The electrical wheelchair consists of two foldable armrests, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Lithiumion battery, a battery charger, a controller and master module. .
Wheelchair frame: Foldable for easy storage and transportation.
Controller and Master module: control the forward, steering and speed adjustment of the electric wheelchair.
Battery: It was installed at the bottom of the wheelchair.
Rear wheel (Driving Wheel): equipped with motor and electric brake device.
Front wheel: Provide support to keep the wheelchair stable.
The battery of electrical wheelchair is Lithium-ion 24V, 11AH, and the charger is Input: 100-240VAC,50-
60Hz, 1.2-0.5A, Output:DC24V,3A
The maximum weight limitation of the user is 100kg.
This product can be quickly folded, disassembled, and is easy to place in the trunk of a car or lift upstairs.
The wheelchair is made of high-quality aluminum alloy. The weight without battery is 23kg.
This product is an indoor wheelchair that can be driven indoors or on flat roads near buildings. In principle, it cannot be cross-country. It is not recommended to drive on grass, gravel roads, slopes greater than 12°, and motor vehicle lanes.
5. Intended Use
The Electrical Wheelchair (Model: 9000N) is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to the disabled, the elderly and the infirm for short-distance travel.
6. Test Summary of Non-clinical Testing
The Electrical Wheelchair has been evaluated the safety and performance by lab bench testing according to the following standards:
- . ISO 7176-1: 2014 Wheelchairs - Part 1: Determination of static stability
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- . 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 manoeuving space
- . ISO 7176-6: 2018 Wheelchairs - Part 6: Determination of maximum speed. acceleration and deceleration of electric wheelchairs
- . ISO 7176-7: 1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- ISO 7176-8: 2014 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue . 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 7176-16: 2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices
- . ISO 7176-19:2008 Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles
EMC
- . ISO 7176-21: 2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Biocompatibility
The parts in contact with the user include: Joystick handle , is made of 100% Nitrile rubber; Joystick buttons are made of 100% silica gel; Upper/lower cover of Joystick are made of 100% ABS; Armrest are
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made of 100% polyurethane (PU); Seat cushion, is made of 100% Ployester. All contact materials have passed biological tests and are harmless to humans.
- . ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- . ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
7. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use,
functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Product Code | ITI | ITI | Same |
| Regulation No. | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Class | II | II | Same |
| Product name | Electrical Wheelchair | Electric Wheelchair | Same |
| 510 (k)Number | K221799 | K192739 | -- |
| Models | 9000N | JRWD6010, JRWD6012 | -- |
| Intended Use | The Electrical Wheelchair (Model: 9000N) is a motor-driven, and indoortransportation vehicle with the intendeduse to provide mobility to the disabled,the elderly and the infirm for short-distance travel. | The device is a motor-driven, andindoor transportation vehicle with theintended use to provide mobility to adisabled or an elderly person limited toa seated position. | Same |
| Useenvironment | Indoor use | Indoor use | Same |
| PatientPopulation | This electrical wheelchair is suitablefor short-distance travel for thedisabled and the elderly person. | The electric wheelchair is intended toprovide mobility to a person with adisability or an older adult limited to asitting position | Same |
| Productstructure | Consists of two foldable armrests, abackrest, a seat cushion, a foldableframe, two rear driving wheels with | Consists of two foldable armrests, abackrest, a seat cushion, a foldableframe, two rear driving wheels with hub | Same |
Table1 General Comparison
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| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| hubmotor/electromagnetic brakeassemblies, two pivoting casters, aLithium-ion battery, a battery charger,a controller and master module. | motor/electromagnetic brakeassemblies, two pivoting casters, a Li-ion batteries, an off-board batterycharger, a control panel, and an electricmotor controller. | ||
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Number ofwheels | 4 | 4 | Same |
| Main framematerial | Aluminium alloy | Aluminium alloy | Same |
| Motor | DC 24V* 180W * 2pcs | DC24V* 180W*2pcs | Same |
| Battery | Lithium-ion 24V, 11AH,1pcs | DC 24V 20Ah Lithium-ion, 1 pcs | Subject Devicehas a lower outputcurrent, but thiswill not affect theuse of the productfunction andsafety. |
| Battery charger | Input:AC 100-240V, 50/60HzOutput:DC24V, 3A max | High Power Technology Inc.HP0180WL2Input: 100-240 VACOutput: DC 24V, 6 Amp | Subject Devicehas a lower outputcurrent, but thiswill not affect theuse of the productfunction andsafety. |
Table2 Performance Comparison
| Elements of | Subject Device | Predicate Device | Verdict | |
|---|---|---|---|---|
| Comparison | JRWD6010 | JRWD6012 | ||
| Dimensions | 39.0"x24.0"x38.0" | 38.1"x24.0"x37.0" | 39.3"x23.6"x37.0" | Similar |
| FoldedDimensions | 26.0"x24.0"x16.0" | Not publicly available | -- | |
| Seat Cushionsize | 18.0"x18.0"x3.0" | Not publicly available | -- | |
| Weight,w/Battery | 50lbs./23kg | 58.4 lbs. /26.5kg | 58.2 lbs./26.4kg | Subject Device has alighter weight, but thiswill not affect the use ofthe product function andsafety. |
| Frame design | Foldable/The device consists of a foldableand non-rigid type of powerwheelchair base with rear driveand 2 casters in the front and 2anti-tippers in the rear. | Foldable /The device consists of a foldable andnon-rigid type of power wheelchair basewith rear drive and 2 casters in the frontand two anti-tippers in the rear. | Same | |
| Foldingmechanism | A foldable seat frames(The backrest could be folded to | A foldable seat frames(The backrest could be folded to seat) | Same | |
| Elements of | Predicate Device | |||
| Comparison | Subject Device | JRWD6010 | JRWD6012 | Verdict |
| seat) | ||||
| Front wheel(inch ) | 8 | 8(PU solid tire) | ||
| Rear tire(inch) | 8(PU solid tire) | 10(PU solid tire) | 12(Pneumatic tire) | Smaller sizes of rearwheels, The differencewill not raise any newsafety and effectivenessconcerns. |
| CruisingRange(km) | 15.5 | 20 | Subject Device has ashorter cruising range,but this will not affectthe use of the productfunction and safety. | |
| Obstacleclimbing(mm) | 25 | 50 | Subject Device hasalower obstacle climbing,but this will not affectthe use of the productfunction and safety. | |
| Max. Speed(km/h) | 4.5 | 6 | Subject Device has asmaller Max. speed, butthis will not affect theof the productusefunction and safety. | |
| Static stabilityforward | 18.2° | 21.8° | Both of the devices areevaluated according to | |
| Static stabilityrearward | 18.0° | 19° | standardISO 7176-1:2014, so the different | |
| Static stabilitysideways | Left: 17.6°Right: 16.6° | 19.2° | static stability will notimpact the safety andeffectiveness. | |
| Max. loading(kg) | 220lbs(100kg) | 220lbs (100kg) | Same | |
| Maximumsafeoperationalincline | 10° | 10 degrees | Same | |
| Min. Turningradium | 950mm | 1820mm | The difference in thetuming radius will bringmore convenience whenit turns.The differencewill not raise any newsafety and effectivenessconcerns. | |
| Minimumbrakingdistance | ≤1meter (39inches )flat,≤1.6meter (63 inches) at 3°slope | 1m | Similar | |
| Max SpeedForwards | 2.46mph(3.96km/h) | 3.75 mph (6 km/h) | Both of the devices areevaluated according to | |
| Max. SpeedBackward | 1.57mph(2.52km/h) | 2.80 mph (4.5 km/h) | standardISO 7176-6:2018, so the different | |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| JRWD6010 | JRWD6012 | |||
| will not impact thesafety and effectiveness | ||||
| Controller | Silver Fox Corporation Limited | PG Drives Technology Ltd., new VSI | Different Althoughdifferent controller isused, both the controlsystem, including thejoystick controller, theelectromagnetic brakesare similar. The joystickcontrols the directionsand speed of movement,and when the joystick isreleased, the poweredwheelchair will slowdown to stop and thebrakes willautomatically re-engage.The controller alsoprovides the batterystatus displaying andabnormal conditiondisplaying. Both of thecontrol systems areevaluated according tostandard ISO 7176-14:2008 and softwarevalidation requirementand there are no newsafety and effectivenessconcerns due to thedifference. | |
| Speed controlmethod | Joystick control method | Joystick control method | Same |
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Table3 Safety Comparison
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Main materials | Frame: Aluminiumalloy;Wheel, Armrest: PU;Backrest:polyeter | Frame: Aluminiumalloy;Wheel, Armrest: PU;Backrest: oxford cloth | The material for themain frame is the same.Biocompatibilityevaluation has beencarried out per ISO10993-1. |
| Materialscontacting user | Armrest: PU;Backrest, Seat cushion: polyeterJoystick handle : Nitrile rubber;Joystick buttons: silica gel;Upper/lower cover of Joystick:ABS | Armrest: PU:Backrest: oxford clothSeat: oxford clothnewVSi electric wheelchaircontroller:Joystick knob: Santoprene 101-80;Joystick Gaiter: Silicone 3032(50%) & 5031 (50%)Enclosure Moulding(s): ABS/PCWonderloy PC-540Keypad: Silicone keypad coatings | There are no new safetyand effectivenessconcerns due to thedifference. |
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| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| TC-2407 & CH-6330 | |||
| Biocompatibilityof materialscontacting user | Comply with ISO 10993-1, FDACytotoxicity (ISO 10993-5:2009),Sensitization and IntracutaneousReactivity (ISO 10993-10:2010) | Comply with ISO 10993-1, FDACytotoxicity (ISO 10993-5:2009),Sensitization and IntracutaneousReactivity (ISO 10993-10:2010) | Same |
| Label andLabeling | Conforms to FDA RegulatoryRequirements | Conforms to FDA RegulatoryRequirements | Same |
| Level ofConcern of theSoftware | Moderate | Moderate | Same |
8. Summary of substantial equivalence discussion
The 9000N electrical wheelchair complied with the requirements of ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014. ISO 7176-9:2009. ISO 7176-10:2008. ISO 7176-11:2012. ISO 7176-13:1989. ISO 7176-14:2008. ISO 7176-15:1996, ISO 7176-16:2012, ISO 7176-19:2008, ISO 7176-21:2009, IEC 60601-1-2:2014, ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010..
The intended uses for both devices are the same. Mainframes of two devices are folded by way of front and rear close, and frame materials all meet the Tensile Strength, Yield Load, and Elongation tests. The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14:2008. Software validation is carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012. Maximum obstacle climbing, Max Speed and Static stability different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-2:2001,ISO 7176-6: 2018, ISO 7176-10:2008. The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2010.
The flame retardant test of the seat cushion and armrest of subject device is carried out according to the ISO 7176-16 test. Therefore, the subject device meets the flame retardancy of FDA requirements.
In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate 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.
9. Summary of Clinical Test
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No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electrical wheelchair to its predicate device.
10. Conclusion
The differences between 9000N electrical wheelchair and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that 9000N electrical wheelchair is substantially equivalent to the legally marketed predicate device.
11. Summary Prepared Date
13 June 2022
§ 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).