(155 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: W3331. has a base with Steal frame, one 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 provided text is a 510(k) summary for a Mobility Scooter (Model W3331). This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe an AI/ML powered device, and therefore the majority of the requested information regarding acceptance criteria, study design for AI models, and performance metrics for AI assistance is not applicable.
However, I can extract the general acceptance criteria and the methods used to prove the device meets these criteria as described in the document.
Device: Mobility Scooter (W3331)
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are primarily derived from various ISO 7176 series standards for wheelchairs and scooters, and ISO 10993 for biocompatibility. The reported device performance indicates compliance with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance | Remark |
|---|---|---|
| Biocompatibility | ||
| ISO 10993-5: 2009 (In Vitro Cytotoxicity) & ISO 10993-10: 2010 (Irritation & Skin Sensitization) requirements for user directly contacting materials | All user directly contacting materials are compliant with ISO 10993-5 and ISO 10993-10 requirements. | S.E. (Substantially Equivalent) to predicate |
| Electromagnetic Compatibility (EMC) | ||
| ISO 7176-21: 2009 & IEC 60601-1-2 requirements | EMC performance results meet the requirements of ISO 7176-21. | S.E. to predicate |
| Performance (ISO 7176 series) | ||
| ISO 7176-1: 2014 (Static Stability) | Static stability determined and meets design specification. | S.E. to predicate. Proposed device: Dynamic Stability: 6 degree, Static Stability: 8 degree. Predicate: 9 degree (This indicates a slight performance difference, but considered SE based on the full scope of testing). |
| ISO 7176-2: 2017 (Dynamic Stability) | Dynamic stability determined and meets design specification. | S.E. to predicate |
| ISO 7176-3: 2012 (Effectiveness of Brakes) | Effectiveness of brakes determined and meets design specification. | S.E. to predicate. Proposed device: Time to brake < 1 s, Brake Distance (Normal operation, Horizontal, Forward, Max speed) ≤1.3m. Predicate: Time to brake < 1 s, Brake Distance ≤1.5m. |
| ISO 7176-4: 2008 (Energy consumption/Theoretical Distance Range) | Theoretical distance range determined and meets design specification. | S.E. to predicate. Proposed device: 15 km/9.32 Miles. Predicate: 15 km/9.32 Miles. |
| ISO 7176-5: 2008 (Overall Dimensions, Mass, Maneuvering Space) | Dimensions, mass determined. | S.E. to predicate. Differences in overall dimension, ground clearance, turn radius, front/rear wheel size noted, but considered SE. |
| ISO 7176-6: 2018 (Max speed, acceleration, deceleration) | Dimensions, mass determined (appears to be a copy-paste error in the document, likely refers to speed metrics). | S.E. to predicate. Proposed device: 4.25mph (6.83km/h). Predicate: 6 km/h. |
| ISO 7176-7 (Seating and wheel dimensions) | Seating and wheel dimensions determined. | S.E. to predicate. Differences in armrest distance noted, but considered SE. |
| ISO 7176-8: 2014 (Static, Impact, Fatigue Strengths) | All test results meet requirements in Clause 4 of ISO 7176-8. | S.E. to predicate |
| ISO 7176-9: 2009 (Climatic Tests) | Device continues to function according to manufacturer's specification after climatic tests. | S.E. to predicate |
| ISO 7176-10: 2008 (Obstacle-climbing ability) | Obstacle-climbing ability determined. | S.E. to predicate |
| ISO 7176-11: 2012 (Test dummies) | Test dummies used meet requirements of ISO 7176-11. | S.E. to predicate |
| ISO 7176-13: 1989 (Coefficient of friction of test surfaces) | Coefficient of friction of test surfaces determined. | S.E. to predicate |
| ISO 7176-14: 2008 (Power and control systems) | All test results meet requirements in Clauses 7-17 of ISO 7176-14. | S.E. to predicate |
| ISO 7176-15: 1996 (Information disclosure, documentation, labeling) | Information disclosure, documentation, and labeling meet requirements of ISO 7176-15. | S.E. to predicate |
| ISO 16840-10: 2021 (Resistance to ignition of postural support devices) | Performance of resistance to ignition meets requirements of ISO 16840-10:2021. | S.E. to predicate (predicate used ISO 7176-16) |
| ISO 7176-25: 2013 (Batteries and chargers) | Performance of batteries and charger meets requirements in Clause 5 and 6 of ISO 7176-25. | S.E. to predicate |
| Labeling | ||
| Conforms to FDA Regulatory requirements | Conforms to FDA Regulatory. | S.E. to predicate |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical tests conducted on the device itself (Mobility Scooter Model W3331) to evaluate its performance against engineering standards. This is not a study involving patient data, test sets, or populations. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) as typically applied to AI/ML or clinical studies is not applicable. The "test set" in this context refers to the physical device being tested against various standard requirements.
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 information is not applicable as the document describes physical device testing against established engineering standards (ISO 7176, ISO 10993) rather than an AI/ML model where expert ground truth is typically assessed. The "ground truth" here is the pass/fail criteria defined by the ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no human adjudication process described for establishing ground truth in this non-clinical engineering testing. The compliance is determined by measurements against standard specifications.
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
This is not applicable as the device is a physical mobility scooter, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical mobility scooter and does not involve AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the performance specifications and acceptance criteria defined by international engineering standards (ISO 7176 series and ISO 10993 series). The device's performance is measured against these objective, predefined values.
8. The sample size for the training set
This is not applicable as the device is a physical mobility scooter and does not involve an AI model with a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical mobility scooter and does not involve an AI model with a training set.
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June 5, 2024
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave Shanghai, Shanghai 200122 China
Re: K240008
Trade/Device Name: Mobility Scooter (W3331) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: December 26, 2023 Received: January 2, 2024
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 (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.
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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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices
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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Mobility Scooter (W3331)
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."
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510(k) Summary K240008
Document Prepared Date: 2024/04/18
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 Title: Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: jiawei.wu@sungoglobal.com
Secondary contact: Mr. Raymond Luo Title: Technical Director Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda(@sungoglobal.com
B. Device:
Trade Name: Mobility Scooter
Common Name: Scooter
Model: W3331
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: K222495
Classification Name: Motorized three-wheeled vehicle
Regulation Number: 890.3800
Device Name: Mobility Scooter
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Model: W3331F
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
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: W3331. has a base with Steal frame, one 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 Test Conclusion
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 Powered Wheelchairs >
- 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 of electric 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 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 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 electrically powered >
2 of 8
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wheelchairs and scooters - Requirements and test methods
-
ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
-
ISO 16840-10:2021 Wheelchair seating Part 10: Resistance to ignition of postural support devices Requirements and test method.
- 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 | Predicate Device (K222495) | Remark | |
|---|---|---|---|---|
| Manufacturer | Zhejiang Innuovo RehabilitationDevices Co., Ltd | Zhejiang Innuovo RehabilitationDevices Co., Ltd | Same | |
| Common orUsual name | Scooter | Scooter | Same | |
| Model(s) | W3331 | W3331F | -- | |
| 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 withthe intended use to provide mobility toa disabled or elderly person limited toa seated position. | S.E. | |
| Overalldimension | 1110 mm x 560 mm x 840 mm | 940 mm x 500 mm x 840 mm | Analysis | |
| 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 | 196 x 66 mm | 190 x 55 mm | Analysis | |
| Front WheelsQuantity | 1 | 1 | S.E. | |
| Rear wheelsize | 196 x 66 mm | 190 x 55 mm | Analysis | |
| Rear WheelsQuantity | 2 | 2 | S.E. | |
| Groundclearance | 35 mm | 45 mm | Analysis | |
| MaxLoading( onlevel ground) | 120kg | 120kg | S.E. | |
| Turn Radius | 925 mm | 1200mm | Analysis | |
| Motor output | LINIX 24 V 180W | 24 V 180W | Analysis | |
| DriveSystem | Rear Wheel Drive | Rear Wheel Drive | S.E. | |
| Brakes | Electromagnetic brake | Electromagnetic brake | S.E. | |
| Battery | Long Way Lead-acid 12V12Ah*2 | Lead-acid 12V12Ah*2 | Analysis | |
| Charger | 24V/2A | 24V/2A | S.E. | |
| Max Speed | 4.25mph (6.83km/h) | 6 km/h | Analysis. | |
| Slope GradeAbility | Dynamic Stability :6 degreeStatic Stability: 8 degree | 9 degree | Analysis | |
| TravelDistance | 15 km/9.32 Miles | 15 km/9.32 Miles | S.E. | |
| Arm Rests(Distancebetweenarmrests) | 37-50.5 cm | 44-56 cm | Analysis | |
| Controller | British PG 45A | 45A | Analysis | |
| Time tobrake | < 1 s | < 1 s | S.E. | |
| BrakeDistance-Normaloperation(Horizontal-Forwa rd-Max speed) | ≤1.3m | ≤1.5m | Analysis | |
| Batteryweight | 8.8kg | 8.8kg | S.E. | |
| Base weight(notincludingbattery) | 31.2kg | 38kg | 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. |
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I. Difference analysis
The design and technological characteristics of the proposed device is identical to the predicate device. There are minor differences between the device is the brand/suppliler of controller, battery and motor. and the proposed device uses British PG 45A controller, Long Way Lead-acid Batteries and LINIX 180W Motor. Other minor difference include Overall Dimension, Front & Rear wheel size, Ground clearance, Turn Radius, Max Speed, Slope Grade Ability, Arm Rests (Distance between armrests) and Brake Distance-Normal
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Operation (Horizontal-Forwa rd-Max speed)
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 (K222495).
The Mobility Scooter Model W3331 in its final finished form is identical to the Mobility Scooter Model W3331F in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)
| 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 and IEC 60601-1-2 | 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 dimensionshas been determined after the testingaccording to the ISO 7176-7, | The seating and wheel dimensionshas been determined after the testingaccording to the ISO 7176-7, | S.E. |
| ISO7176-8 | All test results meet therequirements in Clause 4 of ISO7176-8 | All test results meet therequirements in Clause 4 of ISO7176-8 | S.E. |
| ISO7176-9 | The test results shown that the deviceunder tests could continue tofunction according to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9 | The test results shown that the deviceunder tests could continue to functionaccording to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9 | S.E. |
| ISO7176-10 | The obstacle-climbing ability ofdevice has been determined after thetesting according to the ISO 7176-10, | The obstacle-climbing ability ofdevice has been determined after thetesting according to the ISO 7176-10, | S.E. |
| ISO7176-11 | The test dummies used in the testingof ISO 7176 series are meet therequirements of ISO 7176-11 | The test dummies used in the testingof ISO 7176 series are meet therequirements of ISO 7176-11 | S.E. |
| ISO7176-13 | The coefficient of friction of testsurfaces has been determined, whichcould be used in other 7176 series testsinvolved | The coefficient of friction of testsurfaces has been determined, whichcould be used in other 7176 series testsinvolved | S.E. |
| 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 | S.E. |
| ISO7176-15 | The test results shown thatinformation disclosure,documentation and labelling ofdevice meet the requirements of ISO7176-15 | The test results shown thatinformation disclosure,documentation and labelling ofdevice meet the requirements of ISO7176-15 | S.E. |
| ISO7176-16/ISO 16840-10:2021 | The performance of resistance toignition meet the requirements ofISO 16840-10:2021 | The performance of resistance toignition meet the requirements ofISO 7176-16 | S.E. |
| ISO 7176-21 | The EMC performance results meetthe requirements of ISO 7176-21 | The EMC performance results meet therequirements of ISO 7176-21 | S.E. |
| ISO7176-25 | The performance of batteries andcharger of device meet theRequirements in Clause 5 and 6 ofISO 7176-25 | The performance of batteries andcharger of device meet theRequirements in Clause 5 and 6 of ISO7176-25 | S.E. |
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J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission, the Mobility scooter, Model W3331, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K222495.
§ 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).