(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: W3468A, has a base with Steal frame, two front wheels, 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 provided document is a 510(k) premarket notification for a Mobility Scooter (Model: W3468A). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical safety and effectiveness through extensive studies involving human subjects and AI performance metrics.
Therefore, many of the requested details, such as those related to AI algorithm performance, expert ground truth establishment, MRMC studies, or training set specifics, are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally that the Mobility Scooter (Model: W3468A) meets the specifications outlined in various ISO 7176 series standards and demonstrates performance comparable to the predicate device (K182471).
| Performance Measure/Test | Acceptance Criteria (Implicit: Meet standard requirements & be comparable to predicate) | Reported Device Performance |
|---|---|---|
| Biocompatibility (User-contacting materials) | Compliance with ISO10993-5 and ISO10993-10 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. |
| EMC | Compliance with ISO7176-21. | The EMC performance results meet the requirements of ISO 7176-21. |
| General Performance | Compliance with ISO7176 series. | Test results demonstrate compliance with ISO7176 series standards. |
| Label and Labeling | Conforms to FDA Regulatory requirements. | Conforms to FDA Regulatory. |
| ISO 7176-1 (Static Stability) | Meet design specification. | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. |
| ISO 7176-2 (Dynamic Stability) | Meet design specification. | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. |
| ISO 7176-3 (Brake Effectiveness) | Meet design specification. | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. |
| ISO 7176-4 (Theoretical Distance Range) | Meet design specification. | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification. |
| ISO 7176-5 (Dimensions, Mass) | Determination of dimensions, mass. | The dimensions, mass has been determined after the testing according to the ISO 7176-5. |
| ISO 7176-6 (Max Speed, Acceleration, Deceleration) | Determination of max speed, acceleration, deceleration. | (Implicitly tested under ISO 7176 series, with specified Max Speed of 6.4km/h) |
| ISO 7176-7 (Seating and Wheel Dimensions) | Determination of seating and wheel dimensions. | The seating and wheel dimensions has been determined after the testing according to ISO 7176-7. |
| ISO 7176-8 (Static, Impact, Fatigue Strengths) | Meet requirements in Clause 4 of ISO 7176-8. | All test results meet the requirements in Clause 4 of ISO 7176-8. |
| ISO 7176-9 (Climatic Tests) | Device continues to function according to manufacturer's specification. | 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. |
| ISO 7176-10 (Obstacle-climbing ability) | Determination of obstacle-climbing ability. | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10. |
| ISO 7176-11 (Test Dummies) | Test dummies meet requirements of ISO 7176-11. | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11. |
| ISO 7176-13 (Coefficient of Friction of Test Surfaces) | Determination of coefficient of friction. | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved. |
| ISO 7176-14 (Power and Control Systems) | Meet requirements in Clauses 7-15, 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. |
| ISO 7176-15 (Information Disclosure, Documentation, Labeling) | Meet requirements of ISO 7176-15. | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15. |
| ISO 7176-16 (Resistance to Ignition) | Meet requirements of ISO 7176-16. | The performance of resistance to ignition meet the requirements of ISO 7176-16. |
| ISO 7176-25 (Batteries and Chargers) | Meet Requirements in Clause 5 and 6 of ISO 7176-25. | The performance of batteries and charger of device meet the Requirements in Clause 5 and 6 of ISO 7176-25. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials or algorithm testing. The evaluation involved non-clinical testing against various ISO standards. These standards define the test conditions, procedures, and potentially the number of tests or samples (e.g., number of test cycles for fatigue, number of stability tests), but a single overarching "sample size" isn't provided.
- Data Provenance: The tests are "Non-clinical tests" conducted to verify design specifications and substantial equivalence. The document does not specify a country of origin for the testing data itself, beyond the applicant being from China. These are laboratory/engineering tests, not human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This submission does not involve AI performance evaluation or ground truth established by medical experts. The "ground truth" here is the adherence to established international safety and performance standards (ISO 7176 series) for mobility scooters. The experts involved would be engineers and testing personnel verifying compliance with these standards, not medical professionals establishing diagnostic ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. There's no mention of an adjudication process in the sense of resolving discrepancies between expert opinions, as this is not a study involving human interpretation of medical images or data. The "adjudication" is the determination of whether the device met the requirements of the specified ISO standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. This is a 510(k) submission for a physical medical device (mobility scooter), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no AI algorithm involved in this device.
7. The type of ground truth used
- The "ground truth" for this submission is based on engineering and performance standards (ISO 7176 series) and the demonstrated physical properties and function of the device meeting these standards. These are objective measurements and comparisons against established criteria for device safety and performance, rather than expert consensus on medical pathology or clinical outcomes.
8. The Sample Size for the Training Set
- Not Applicable. There is no AI component requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. There is no AI component requiring a training set or its associated ground truth establishment.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services 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.
March 24, 2022
Zhejiang Innuovo Rehabilitation Devices Co., Ltd % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K220206
Trade/Device Name: Mobility Scooter (Model: W3468A) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: January 25, 2022 Received: January 25, 2022
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.
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
{1}------------------------------------------------
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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K220206
Device Name Mobility Scooter (Model: W3468A)
Indications for Use (Describe)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) Summary
Document prepared date: 2022/1/21
Applicant: A. Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejjang.China Contact Person: Leo Zheng Tel: + 86 18358936043
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: haiyu.wang@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 Common Name: Scooter Model: W3468A
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: K182471 Device Name: Scooter Model: KPL001 Tianjin Kepler Vehicle Industry Co. Ltd.
D. Indications for use of the device :
{4}------------------------------------------------
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: W3468A, has a base with Steal frame, two front wheels, 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 A Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And A 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 Powered Wheelchairs >
- ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes A
- ISO 7176-4, Third edition 2008-10-01, Wheelchairs Part 4: Energy consumption of electric > wheelchairs and scooters for determination of theoretical distance range
- A 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 A
- 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 ability of A electrically powered wheelchairs
- ISO 7176-11:2012 Wheelchairs Part 11: Test dummies. A
- ISO 7176-13, First edition 1989-08-01, Wheelchairs Part 13: Determination of coefficient A 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, Wheelchars Part 15: Requirements for information disclosure, documentation > and labeling
- A ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices.
{5}------------------------------------------------
- ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for electromagnetic > compatibility of electrically powered wheelchairs and scooters, and battery chargers
- ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered wheelchairs >
G. Clinical Test Conclusion
No clinical study is included in this submission.
H. Comparison with predicate Device
Table 1 General Comparison
| Elements ofComparison | Subject Device(s) | Predicate Device (K182471) | Remark |
|---|---|---|---|
| Manufacturer | Zhejiang Innuovo RehabilitationDevices Co.,Ltd | Tianjin Kepler Vehicle Industry Co.Ltd. | -- |
| Common orUsual name | Scooter | Scooter | Same |
| Model(s) | W3468A | KPL001 | -- |
| 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 | 1075 mm x 500 mm x 920 mm | 1030mm/40.6" x 630mm/24.8" x920mm/36.2" | Similar |
| 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 | 200 x 50 mm | 190 x 54 mm | Analysis |
| Front WheelsQuantity | 2 | 2 | S.E. |
| Rear wheelsize | 200 x 50 mm | 215 x 70 mm | Analysis |
| Rear WheelsQuantity | 2 | 2 | S.E. |
| Groundclearance | 100mm(3.9") | 45 mm(1.8") | Analysis |
| MaxLoading( onlevel ground) | 136kg | 120 kg/265 lbs approx. | Analysis |
| Turn Radius | 1350mm(53") | 1300 mm(51.2") | Analysis |
| Motor output | 250W | 24 V 180W | Analysis |
| Drive System | Rear Wheel Drive | Rear Wheel Drive | S.E. |
| Brakes | Electromagnetic brake | Electromagnetic brake | S.E. |
| Battery | Lead Acid 12V x 2 (12Ah or 20Ah) | Lead-acid 24V/12AH | S.E. |
| Charger | 24V/2A | 24V/2A | S.E. |
| Max Speed | 6.4km/h | 6.6 km/h | S.E. |
| Slope GradeAbility | 9 degree | 0-12 degree | Analysis |
| TravelDistance | 14km / 9 Miles (12Ah) | 15 km/9.32 Miles | S.E. |
| Arm Rests(Distancebetweenarmrests) | 44 cm | No available data | Analysis |
| Controller | PG45A | PG45A | S.E. |
| Time tobrake | 0.7-1s | < 1 s | S.E. |
| BrakeDistance-Normaloperation(Horizontal-Forward-Max speed) | ≤1.5m | 1m | S.E. |
| Batteryweight | Battery Pack (12Ah) – 9kg (20lb)Battery Pack (20Ah) – 14kg (31lb) | 10.2 kg/22.5 lbs | Analysis |
| Base weight(notincludingbattery) | 45kg | 50 kg/110 lbs | Analysis |
| 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. |
{6}------------------------------------------------
I. Difference analysis
The design and technological characteristics of the Electric Scooter is similar to the predicates chosen. There are minor differences between the devices including Front & Rear wheel size, ground clearance, Max Loading (on level ground), Turn Radius, Motor output, Max Speed, Slope Grade Ability, Battery weight and Base weight (not including battery). All of the parameter with difference have been tested according to ISO7176 series standards and the test records support its safety and effectiveness. There
{7}------------------------------------------------
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 (K182471).
| Item | Proposed Device | Predicate Devices | Results |
|---|---|---|---|
| Biocompatibility | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 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
| 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 dimensionshas been determined after the testingaccording to theISO 7176-7, | The seating and wheel dimensionshas been determined after the testingaccording to theISO 7176-7, | S.E. |
| ISO7176-8 | All test results meet therequirements in Clause 4 of ISO | All test results meet therequirements in Clause 4 of ISO | S.E. |
| The test results shown that the device | The test results shown that the device | S.E. | |
| under tests could continue to | under tests could continue to function | ||
| ISO7176-9 | function according to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9 | according to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9 | |
| The obstacle-climbing ability of | The obstacle-climbing ability of | ||
| ISO7176-10 | device has been determined after thetesting according to the ISO 7176-10, | device has been determined after thetesting according to the ISO 7176-10, | |
| The test dummies used in the testing | The test dummies used in the testing | ||
| ISO7176-11 | of ISO 7176 series are meet therequirements of ISO 7176-11 | of ISO 7176 series are meet therequirements of ISO 7176-11 | |
| The coefficient of friction of testsurfaces has | The coefficient of friction of testsurfaces has | ||
| ISO7176-13 | been determined, which could be usedin other 7176 series tests involved | been determined, which could be usedin other 7176 series tests involved | |
| ISO7176-14 | All test results meet therequirements in Clause 7, 8, 9, 10,11, 12, 13, 14, 15, 17 of ISO 7176-14 | All test results meet therequirements in Clause 7, 8, 9, 10,11, 12, 13, 14, 15, 17 of ISO 7176-14 | |
| The test results shown that | The test results shown that | ||
| ISO7176-15 | information disclosure,documentation and labelling ofdevice meet the requirements ofISO 7176-15 | information disclosure,documentation and labelling ofdevice meet the requirements of ISO7176-15 | |
| ISO7176-16 | The performance of resistance toignition meet the requirements ofISO 7176-16 | The performance of resistance toignition meet the requirements ofISO 7176-16 | |
| ISO 7176-21 | The EMC performance results meetthe requirements of ISO 7176-21 | The EMC performance results meet therequirements of ISO 7176-21 | |
| The performance of batteries and | The performance of batteries and | ||
| ISO7176-25 | charger of device meet theRequirements in Clause 5 and 6 ofISO 7176-25 | charger of device meet theRequirements in Clause 5 and 6 of ISO7176-25 |
7176-8
7176-8
Table 3 Safety comparison
{8}------------------------------------------------
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Mobility scooter, model W3468A , is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K182471.
§ 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).