(58 days)
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.
The Mobility Scooter, Models: W3431D, has a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever. speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.
The device discussed is a Mobility Scooter (Models: W3431D). Its acceptance criteria and performance are based on non-clinical testing against a series of ISO 7176 standards.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (ISO Standard) | Performance/Test Results |
|---|---|
| ISO 10993-5: 2009 (Cytotoxicity) | All user directly contacting materials are compliant. |
| ISO 10993-10: 2010 (Irritation & Skin Sensitization) | All user directly contacting materials are compliant. |
| ISO 7176-1: 2014 (Static Stability) | The Static stability has been determined after testing and meets its design specification. |
| ISO 7176-2: 2017 (Dynamic Stability) | The dynamic stability has been determined after testing and meets its design specification. |
| ISO 7176-3: 2012 (Brake Effectiveness) | The effectiveness of brakes has been determined after testing and meets its design specification. |
| ISO 7176-4: 2008 (Energy consumption/Theoretical Distance Range) | The theoretical distance range has been determined after testing and meets its design specification. |
| ISO 7176-5: 2008 (Overall Dimensions, Mass, Maneuvering Space) | Dimensions and mass have been determined after testing. Results show the device has overall dimensions of 1020 mm x 500 mm x 840 mm and a base weight of 42kg (not including battery). |
| ISO 7176-6: 2018 (Max Speed, Acceleration, Deceleration) | The dimensions, mass has been determined after the testing according to ISO 7176-5 (note: document appears to repeat ISO 7176-5 for this item, but the standard title aligns with speed, acceleration, deceleration). Max Speed: 6 km/h. |
| ISO 7176-7 (Seating and Wheel Dimensions) | The seating and wheel dimensions have been determined after testing. Front wheel size: 190 x 55 mm; Rear wheel size: 190 x 55 mm; Arm Rests (Distance between armrests): 44-56 cm. |
| ISO 7176-8: 2014 (Static, Impact, Fatigue Strengths) | All test results meet the requirements in Clause 4 of ISO 7176-8. |
| ISO 7176-9: 2009 (Climatic Tests) | The test results show that the device could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9. |
| ISO 7176-10: 2008 (Obstacle-climbing ability) | The obstacle-climbing ability of the device has been determined after testing. Slope Grade Ability: 9 degree. |
| ISO 7176-11: 2012 (Test Dummies) | The test dummies used in the testing of the ISO 7176 series meet the requirements of ISO 7176-11. |
| ISO 7176-13: 1989 (Coefficient of Friction of Test Surfaces) | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved. |
| ISO 7176-14: 2008 (Power and Control Systems) | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. |
| ISO 7176-15: 1996 (Information Disclosure, Documentation and Labeling) | The test results shown that information disclosure, documentation and labeling of the device meets the requirements of ISO 7176-15. |
| ISO 7176-16: 2012 (Resistance to Ignition) | The performance of resistance to ignition meets the requirements of ISO 7176-16. |
| ISO 7176-21: 2009 (EMC) | The EMC performance results meet the requirements of ISO 7176-21. |
| ISO 7176-25: 2013 (Batteries and Chargers) | The performance of batteries and charger of the device meet the requirements of ISO 7176-25. |
| General Performance Metrics | Max Loading (on level ground): 120kg; Turn Radius: 1650mm; Motor output: 24 V 180W; Drive System: Rear Wheel Drive; Brakes: Electromagnetic brake; Battery: Lead-acid 12V12Ah*2; Charger: 24V/2A; Time to brake: 0.7-1s; Brake Distance - Normal operation (Horizontal - Forward - Max speed): ≤1.5m; Travel Distance: 15 km/9.32 Miles. |
| Operating surface & environment | Indoor use and restricted outdoor use on pavements or paved footpaths only. |
The study that proves the device meets the acceptance criteria is a series of non-clinical tests conducted to verify that the proposed device met all design specifications and was substantially equivalent (SE) to the predicate device (K222507). These tests were performed in accordance with the specified ISO standards mentioned above.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set. It refers to "the device" implying testing was done on one or more units of the Mobility Scooter (Models: W3431D). The tests are non-clinical, meaning they are likely engineering/performance tests on manufactured units, not studies involving human subjects or medical data. The provenance of the data is from Zhejiang Innuovo Rehabilitation Devices Co., Ltd, located in Dongyang, Zhejiang, China. The testing appears to be prospective in nature, performed on the device to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a non-clinical device safety and performance study. Therefore, the concept of "experts establishing ground truth for a test set" as would be used in a medical imaging or diagnostic device study is not applicable. The "ground truth" here is compliance with the engineering and safety standards (ISO 7176 series and ISO 10993 series). The evaluation would have been performed by qualified testing personnel and engineers, whose qualifications are not detailed in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of non-clinical device performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective expert review of medical data. The tests performed are objective, quantitative measurements against established international engineering standards.
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
Not applicable. This is a non-clinical submission for a mobility scooter, which does not involve "human readers" or "AI assistance" in the context of medical image interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-driven device. It is a physical medical device (mobility scooter).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is its compliance with internationally recognized engineering and safety standards (ISO 7176 series and ISO 10993 series). The tests are designed to objectively measure the device's physical and mechanical properties and performance against the specified criteria within these standards.
8. The sample size for the training set
Not applicable. This is a non-clinical device performance and safety study for a physical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI or machine learning model in this submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 14, 2023
Zhejiang Innuovo Rehabilitation Devices Co., Ltd % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Century Ave., Shanghai, Shanghai 200122 China
Re: K231428
Trade/Device Name: Mobility Scooter (Models: W3431D) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: May 17, 2023 Received: May 17, 2023
Dear Jarvis Wu:
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.
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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 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. Julia E. Slocomb 2023.07.14 09:18:05 -04'00' -5 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
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Indications for Use
510(k) Number (if known) K231428
Device Name Mobility Scooter (Models: W3431D)
Indications for Use (Describe)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ---------------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
Document Prepared Date: 2023/4/27
Applicant: A.
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China Contact Person: Grace Li Tel: + 86 15924234767
Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: zxfda@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Mobility Scooter (Models:W3431D) Common Name: Scooter Model: W3431D 510Knumber: K231428 Regulatory Information Classification Name: Motorized three-wheeled vehicle Classification: Class II. Product code: INI Regulation Number: 890.3800 Review Panel: Physical Medicine
C. Predicate device:
510Knumber: K222507
Device Name: Mobility Scooter
Model: W3431Q, W3431R
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
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D. Indications for use of the device:
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.
E. Device Description:
The Mobility Scooter, Models: W3431D, has a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever. speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.
F. Non-Clinical TestConclusion
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 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
-
ISO 7176-1: 2014, Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017, Wheelchairs Part 2: Determination of dynamic stability of PoweredWheelchairs >
- ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes >
-
ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption ofelectric wheelchairs and scooters for determination of theoretical distance range
- ISO 7176-5, Second edition 2008-06-01, 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 Powered Wheelchairs
-
ISO 7176-7. 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 Powered Wheelchairs
-
ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing abilityof electrically powered wheelchairs
-
ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies.
- ISO 7176-13, First edition 1989-08-01, Wheelchairs Part 13: Determination of coefficient > of friction of test surfaces
-
ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electricallypowered 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 supportdevices.
- ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods forelectromagnetic V
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- ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered wheelchairs >
G. Clinical TestConclusion
No clinical study is included in this submission.
H. Comparison with predicate Device
Table 1 General Comparison
| Elements ofComparison | Subject Device (K231428) | Predicate Device (K222507) | Remark |
|---|---|---|---|
| Manufacturer | Zhejiang Innuovo RehabilitationDevices Co.,Ltd | Zhejiang Innuovo RehabilitationDevices Co.,Ltd | Same |
| Common orUsual name | Scooter | Scooter | Same |
| Model(s) | W3431D | W3431Q, W3431R | -- |
| Indicationsfor use | It is a motor driven, indoor andoutdoor transportation vehicle with theintended use to provide mobility to adisabled or elderly person limited to aseated position. | It is a motor driven, indoor andoutdoor transportation vehicle with theintended use to provide mobility to adisabled or elderly person limited to aseated position. | S.E. |
| Overalldimension | 1020 mm x 500 mm x 840 mm | 1020 mm x 500 mm x 840 mm | S.E. |
| FrameMaterial | Steel | Steel | S.E. |
| Frame style | Foldable seat, removable battery pack,disassemble for transport | Foldable seat, removable battery pack,disassemble for transport | S.E. |
| Front wheelsize | 190 x 55 mm | 190 x 55 mm | S.E. |
| Front WheelsQuantity | 2 | 2 | S.E. |
| Rear wheelsize | 190 x 55 mm | 190 x 55 mm | S.E. |
| Rear WheelsQuantity | 2 | 2 | S.E. |
| Groundclearance | 45 mm | 45 mm | S.E. |
| MaxLoading( onlevel ground) | 120kg | 120kg | S.E. |
| Turn Radius | 1650mm | 1650mm | S.E. |
| Motor output | 24 V 180W | 24 V 180W | S.E. |
| Drive System | Rear Wheel Drive | Rear Wheel Drive | S.E. |
| Brakes | Electromagnetic brake | Electromagnetic brake | S.E. |
| Battery | Lead-acid 12V12Ah*2 | Lead-acid 12V12Ah*2 | S.E. |
| Charger | 24V/2A | 24V/2A | S.E. |
| Max Speed | 6 km/h | 6 km/h | S.E. |
| Slope GradeAbility | 9 degree | 9 degree | S.E. |
| TravelDistance | 15 km/9.32 Miles | 15 km/9.32 Miles | S.E. |
| Arm Rests(Distancebetweenarmrests) | 44-56 cm | 44-56 cm | S.E. |
| Controller | PG45A | 45A | Analysis |
| Time tobrake | 0.7-1s | < 1 s | S.E. |
| BrakeDistance-Normaloperation(Horizontal-Forwa rd-Max speed) | ≤1.5m | ≤1.5m | S.E. |
| Batteryweight | 8.8kg | 8.8kg | S.E. |
| Base weight(notincludingbattery) | 42kg | 42kg | S.E. |
| Operatingsurface &environment | Indoor use and restricted outdoor useon pavements or paved footpaths only. | Indoor use and restricted outdoor useon pavements or paved footpaths only. | S.E. |
| Remotecontrol | None | None | S.E. |
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Zhejiang Innuovo Rehabilitation Devices Co.,Ltd No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China
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I. Difference analysis
The design and technological characteristics of the proposed device scooter is similar to the predicate device. There are minor differences between the device is the controller brand, the proposed device uses British PG 45A controller.
According to ISO7176 series standards and the test records support its safety and effectiveness. There is no deleterious effect on safety and effectiveness due to the minor differences do not influence the intended use of the device. Therefore, the proposed Scooter is substantially equivalent (SE) to The Scooter (K222507).
| Item | Proposed Device | Predicate Devices | Results |
|---|---|---|---|
| Biocompatibility | All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements. | All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements. | S.E. |
| EMC | ISO7176-21 | ISO7176-21 | S.E. |
| Performance | ISO7176 series | ISO7176 series | S.E. |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. |
Table 2 Safety comparison
Table 3 Safety comparison
| Item | Proposed Device | Predicate Devices | Results |
|---|---|---|---|
| ISO7176-1 | The Static stability has beendetermined after the testing accordingto the ISO 7176-1, and test resultsmeet its design specification. | The Static stability has beendetermined after the testing accordingto the ISO 7176-1, and test results meetits design specification. | S.E. |
| ISO7176-2 | The dynamic stability has beendetermined after the testing accordingto the ISO 7176-2, and test resultsmeet its design specification. | The dynamic stability has beendetermined after the testing accordingto the ISO 7176-2, and test results meetits design specification. | S.E. |
| ISO7176-3 | The effectiveness of brakes has beendetermined after the testing accordingto the ISO 7176-3, and test resultsmeet its design specification. | The effectiveness of brakes has beendetermined after the testing accordingto the ISO 7176-3, and test results meetits design specification. | S.E. |
| ISO7176-4 | The theoretical distance range hasbeen determined after the testingaccording to the ISO 7176-4, and testresults meet its design specification. | The theoretical distance range hasbeen determined after the testingaccording to the ISO 7176-4, and testresults meet its design specification. | S.E. |
| ISO7176-5 | The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5, | The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5, | S.E. |
| ISO7176-6 | The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5. | The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5. | S.E. |
| ISO7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7. | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7. | S.E. |
| ISO7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | S.E. |
| ISO7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | S.E. |
| ISO7176-10 | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | S.E. |
| ISO7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | S.E. |
| ISO7176-13 | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | S.E. |
| ISO7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | S.E. |
| ISO7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | S.E. |
| ISO7176-16 | The performance of resistance to ignition meet the requirements of ISO 7176-16 | The performance of resistance to ignition meet the requirements of ISO 7176-16 | S.E. |
| ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | S.E. |
| ISO7176-25 | The performance of batteries and charger of device meet the | The performance of batteries and charger of device meet the | S.E. |
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| ISO 7176-25 | 7176-25 | |||
|---|---|---|---|---|
| -- | ------------- | --------- | -- | -- |
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Mobility scooter, model:W3431D , is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K222507.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).