(194 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 Scooters, Models: W3431Q, W3431R, have a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electric motor, 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) Summary for a Mobility Scooter (Models: W3431Q, W3431R). This type of regulatory submission is for a medical device that aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or significant improvements over existing technology through clinical studies.
Therefore, the acceptance criteria and study that proves the device meets those criteria are not related to a traditional clinical trial or AI/imaging performance metrics. Instead, the "acceptance criteria" here refer to demonstrating that the new device meets established safety and performance standards relevant for a mobility scooter and is substantially equivalent to a previously cleared device.
Here's an analysis based on the provided document, addressing the prompt's points where applicable for this type of submission:
Acceptance Criteria and Device Performance (for a Mobility Scooter)
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a predicate device (K220206) and compliance with relevant international standards for wheelchairs and mobility scooters (ISO 7176 series and ISO 10993 for biocompatibility). The study undertaken to prove this involved non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on ISO Standards & Predicate Equivalence) | Reported Device Performance (as stated in the document) | Metric | Achieved (Y/N) |
|---|---|---|---|
| Safety - Biocompatibility | Product materials in direct contact with user comply with ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization). | Compliance with ISO 10993-5 & 10 | Y (S.E. to predicate) |
| Safety - Electromagnetic Compatibility (EMC) | Product complies with ISO 7176-21 requirements. | Compliance with ISO 7176-21 | Y (S.E. to predicate) |
| Static Stability | Device determines static stability per ISO 7176-1, meeting design specifications. | Compliance with ISO 7176-1 | Y (S.E. to predicate) |
| Dynamic Stability | Device determines dynamic stability per ISO 7176-2, meeting design specifications. | Compliance with ISO 7176-2 | Y (S.E. to predicate) |
| Brake Effectiveness | Device determines brake effectiveness per ISO 7176-3, meeting design specifications. | Compliance with ISO 7176-3 | Y (S.E. to predicate) |
| Theoretical Distance Range | Device determines energy consumption for theoretical distance range per ISO 7176-4, meeting design specifications. | Compliance with ISO 7176-4 | Y (S.E. to predicate) |
| Overall Dimensions, Mass, and Maneuvering Space | Device determines per ISO 7176-5. | Compliance with ISO 7176-5 | Y (S.E. to predicate) |
| Maximum Speed, Acceleration, Deceleration | Device determines per ISO 7176-6. | Compliance with ISO 7176-6 | Y (S.E. to predicate) |
| Seating & Wheel Dimensions | Device determines per ISO 7176-7. | Compliance with ISO 7176-7 | Y (S.E. to predicate) |
| Static, Impact, and Fatigue Strengths | Device meets requirements in Clause 4 of ISO 7176-8. | Compliance with ISO 7176-8 | Y (S.E. to predicate) |
| Climatic Tests | Device continues to function per manufacturer's specification after climatic tests specified in Clause 8 of ISO 7176-9. | Compliance with ISO 7176-9 | Y (S.E. to predicate) |
| Obstacle-Climbing Ability | Device determines per ISO 7176-10. | Compliance with ISO 7176-10 | Y (S.E. to predicate) |
| Test Dummies | Test dummies used meet ISO 7176-11 requirements. | Compliance with ISO 7176-11 | Y (S.E. to predicate) |
| Coefficient of Friction of Test Surfaces | Determined per ISO 7176-13 for other 7176 series tests. | Compliance with ISO 7176-13 | Y (S.E. to predicate) |
| Power and Control Systems | Device meets requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. | Compliance with ISO 7176-14 | Y (S.E. to predicate) |
| Information Disclosure, Documentation, Labeling | Device meets ISO 7176-15 requirements. | Compliance with ISO 7176-15 | Y (S.E. to predicate) |
| Resistance to Ignition | Device meets ISO 7176-16 requirements. | Compliance with ISO 7176-16 | Y (S.E. to predicate) |
| Batteries and Chargers | Device meets requirements in Clause 5 and 6 of ISO 7176-25. | Compliance with ISO 7176-25 | Y (S.E. to predicate) |
| Maximum Loading | 120kg | Achieved: 120kg (Compared to Predicate's 136kg, addressed via "Analysis" indicating safety/effectiveness) | Y (Deemed acceptable) |
| Turn Radius | 1650mm | Achieved: 1650mm (Compared to Predicate's 1350mm, addressed via "Analysis") | Y (Deemed acceptable) |
| Max Speed | 6 km/h | Achieved: 6 km/h (S.E. to predicate's 6.4 km/h) | Y |
| Slope Grade Ability | 9 degree | Achieved: 9 degree (S.E. to predicate) | Y |
| Travel Distance | 15 km/9.32 Miles | Achieved: 15 km/9.32 Miles (S.E. to predicate's 14km/9 Miles) | Y |
| Time to brake | < 1 s | Achieved: < 1 s (S.E. to predicate's 0.7-1s) | Y |
| Brake Distance (Normal operation, Horizontal, Forward, Max speed) | ≤1.5m | Achieved: ≤1.5m (S.E. to predicate) | Y |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices tested. The non-clinical tests typically involve testing one or more units of the device to confirm compliance with each specified standard. Given the nature of mechanical/electrical testing, typically a representative sample or even a single unit is sufficient if it demonstrates compliance.
- Data Provenance: The testing was non-clinical (laboratory/bench testing) performed by the manufacturer, Zhejiang Innuovo Rehabilitation Devices Co.,Ltd in China. The data would therefore be prospective from these tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For this type of device and submission, "ground truth" as it relates to expert consensus or clinical diagnosis (e.g., in AI/imaging) is not relevant. The "truth" is established by adherence to the engineering and performance standards (ISO series) and comparison to the predicate device. The experts involved would be engineers and technicians proficient in conducting these specific ISO tests.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1 or 3+1) are for resolving discrepancies in expert interpretations of clinical data, which is not part of this 510(k) submission for a mobility scooter. The "results" are objective measurements and compliance statements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant for this device. It is a method used to evaluate diagnostic performance (e.g., of an AI algorithm or a new imaging modality) involving multiple human readers interpreting cases. This submission focuses on the mechanical, electrical, and safety performance of a mobility scooter against established engineering standards and comparison to a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is not an AI/algorithm-based device. "Standalone performance" is relevant to AI's diagnostic accuracy without human intervention. This device is a mobility scooter.
7. The Type of Ground Truth Used
- Engineering/Performance Standards and Predicate Device Specifications. The "ground truth" for this submission is defined by the technical specifications and performance requirements outlined in the ISO 7176 series of standards (e.g., static stability must meet ISO 7176-1) and the demonstrated performance of the legally marketed predicate device (e.g., maximum speed, braking distance). The tests confirm that the new device's performance aligns with or is sufficiently similar to the predicate and meets safety standards.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device, so there is no training set in the context of data used to train an algorithm. "Training" for this device would refer to the manufacturing processes and quality control, not data training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no "training set" in the context of AI, this question is not applicable. The design and manufacturing of the device would follow established engineering principles and quality management systems to meet the desired performance characteristics.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration".
February 28, 2023
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Century Ave., Shanghai 200122, China Shanghai, Shanghai 200122 China
Re: K222507
Trade/Device Name: Mobility Scooter (Models: W3431Q, W3431R) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: February 23, 2023 Received: February 23, 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.
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, Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222507
Device Name Mobility Scooter (Models: W3431Q, W3431R)
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 K22507
Document Prepared Date: 2023/2/22
A. Applicant:
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,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: W3431Q, W3431R
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:
510k number: K220206 Device Name: Scooter Model: W3468A Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
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Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China
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 Scooters, Models: W3431Q, W3431R, have a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electric motor, 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 maneuvering 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 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 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 tdevices. >
-
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods forelectromagnetic
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Zhejiang Innuovo Rehabilitation Devices Co.,Ltd No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China compatibility of electrically powered wheelchairs and scooters, and battery chargers
- ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered wheelchairs ハ
G. Clinical Test Conclusion
No clinical study is included in this submission.
H. Comparison with predicate Device
Table 1 General Comparison
| Elements ofComparison | Predicate Device (K220206) | Subject Device | Remark |
|---|---|---|---|
| Manufacturer | Zhejiang Innuovo RehabilitationDevices Co.,Ltd | Zhejiang Innuovo RehabilitationDevices Co.,Ltd | Same |
| Common orUsual name | Scooter | Scooter | Same |
| Model(s) | W3468A | 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 | 1075 mm x 500 mm x 920 mm | 1020 mm x 500 mm x 840 mm | 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 55 mm | Analysis |
| Front WheelsQuantity | 2 | 2 | S.E. |
| Rear wheelsize | 200 x 50 mm | 190 x 55 mm | Analysis |
| Rear WheelsQuantity | 2 | 2 | S.E. |
| Groundclearance | 100mm(3.9") | 45 mm | Analysis |
| MaxLoading( onlevel ground) | 136kg | 120kg | Analysis |
| Turn Radius | 1350mm(53") | 1650mm | 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 12V12Ah*2 | S.E. |
| Charger | 24V/2A | 24V/2A | S.E. |
| Max Speed | 6.4km/h | 6 km/h | S.E. |
| Slope GradeAbility | 9 degree | 9 degree | S.E. |
| TravelDistance | 14km / 9 Miles (12Ah) | 15 km/9.32 Miles | S.E. |
| Arm Rests(Distancebetweenarmrests) | 44 cm | 44-56 cm | Analysis |
| Controller | PG45A | 45A | Similar |
| Time tobrake | 0.7-1s | < 1 s | S.E. |
| BrakeDistance-Normaloperation(Horizontal-Forwa rd-Max speed) | ≤1.5m | ≤1.5m | S.E. |
| Batteryweight | Battery Pack (12Ah) – 9kg (20lb)Battery Pack (20Ah) – 14kg (31lb) | 8.8kg | Analysis |
| Base weight(notincludingbattery) | 45kg | 42kg | 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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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 Mobility Scooter is similar to the predicate device. There are minor differences between the devices including Front & Rear wheel size, Ground Clearance, Max Loading, Turn Radius, Motor output, Arm Rests (Distance between armrests), 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 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 Mobility Scooter is substantially equivalent (SE) to The Scooter (K220206).
Table 2 Safety comparison
| 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 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. |
| Zhejiang Innuovo Rehabilitation Devices Co.,LtdNo.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China | |||
| 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 hasbeen determined, which could be usedin other 7176 series tests involved | The coefficient of friction of testsurfaces hasbeen determined, which could be usedin other 7176 series tests involved | 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 ofISO 7176-15 | The test results shown thatinformation disclosure,documentation and labelling ofdevice meet the requirements of ISO7176-15 | S.E. |
| ISO7176-16 | The performance of resistance toignition meet the requirements ofISO 7176-16 | 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 of | The performance of batteries andcharger of device meet theRequirements in Clause 5 and 6 of ISO | S.E. |
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Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
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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 W3431Q, W3431R , is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K220206.
§ 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).