(58 days)
The mobility Scoter is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The Mobility Scooter, Model S1 SPORT, S1 PLUS, MAX SPORT, has a base with Steel frame, two front wheels, 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 controller panel shape is slightly different among the three models, S1 SPORT, S1 PLUS, MAX SPORT. The S1 PLUS has a wind board on the triller, while the other two models do not have. The length of model MAX SPORT is 5cm longer than the other two models.
The provided document is a 510(k) premarket notification for a Mobility Scooter, not an AI/ML medical device. Therefore, the information typically required to describe the acceptance criteria and the study proving an AI/ML device meets those criteria (e.g., sample size for test set, data provenance, expert consensus, MRMC studies, standalone performance, training set details) is not present in this document.
This document describes a traditional medical device (Mobility Scooter) and relies on non-clinical performance testing against recognized standards (ISO 7176 series and ISO 10993 series) and comparison to a predicate device to demonstrate substantial equivalence.
Based on the provided text, here's what can be extracted regarding the device's acceptance criteria and the study proving it meets them, adapting the requested categories to fit the context of this traditional medical device submission:
Device: Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
K Number: K231472
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this medical device are primarily adherence to established international standards for wheelchairs and mobility scooters. The reported device performance is that the device meets or conforms to these standards, thereby demonstrating substantial equivalence to the predicate device.
Table: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Applicable Standard) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - ISO 10993-5:2009 (Tests for In Vitro Cytotoxicity) | All user-directly contacting materials are in compliance with ISO10993-5 requirements. |
| - ISO 10993-10:2010 (Tests For Irritation And Skin Sensitization) | All user-directly contacting materials are in compliance with ISO10993-10 requirements. |
| - ISO 10993-23:2021 (Tests for irritation) | All user-directly contacting materials are in compliance with ISO10993-23 requirements. |
| Electromagnetic Compatibility (EMC): | |
| - ISO 7176-21:2009 (Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters) | The EMC performance results meet the requirements of ISO 7176-21. |
| - IEC 60601-1-2:2014 (Electromagnetic Compatibility Testing) | Conforms to IEC 60601-1-2:2014. |
| Performance (ISO 7176 series): | |
| - ISO 7176-1:2014 (Static stability) | Static stability determined and test results meet design specification. |
| - ISO 7176-2:2017 (Dynamic stability of electric wheelchairs) | Dynamic stability determined and test results meet design specification. |
| - ISO 7176-3:2012 (Effectiveness of brakes) | Effectiveness of brakes determined and test results meet design specification. |
| - ISO 7176-4:2008 (Energy consumption & theoretical distance range) | Theoretical distance range determined and test results meet design specification. |
| - ISO 7176-5:2008 (Dimensions, mass and maneuvering space) | Dimensions and mass determined. |
| - ISO 7176-6:2018 (Maximum speed, acceleration and deceleration) | Maximum speed, acceleration and deceleration determined. |
| - ISO 7176-7:1998 (Seating and wheel dimensions) | Seating and wheel dimensions determined. |
| - ISO 7176-8:2014 (Static, impact and fatigue strength) | All test results meet the requirements in Clause 4 of ISO 7176-8. |
| - ISO 7176-9:2009 (Climatic tests) | 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) | Obstacle-climbing ability determined. |
| - ISO 7176-11:2012 (Test dummies) | Test dummies used in testing meet the requirements of ISO 7176-11. |
| - ISO 7176-13:1989 (Coefficient of friction of test surfaces) | Coefficient of friction of test surfaces determined. |
| - 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) | Information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15. |
| - ISO 7176-16:2012 (Resistance to ignition of postural support devices) | Performance of resistance to ignition meets the requirements of ISO 7176-16. |
| - ISO 7176-22:2014 (Set-up procedures) | All performed tests are set up as requirements of ISO 7176-22. |
| - ISO 7176-25:2013 (Batteries and chargers for powered wheelchairs) | Performance of batteries and charger meet the Requirements in Clause 5 and 6 of ISO 7176-25. |
| Labeling: | |
| - Conforms to FDA Regulatory | Conforms to FDA Regulatory. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a numerical sample size for "test sets" in the context of typical AI/ML validation data. Instead, it refers to the Mobility Scooter device itself undergoing various non-clinical tests. It's implied that the device models (S1 SPORT, S1 PLUS, MAX SPORT) were subjected to these tests as representative units.
- Data Provenance: Not applicable in the AI/ML sense of retrospective/prospective clinical data. The "data" here are the results from the non-clinical performance and safety tests conducted on the physical device. The testing was conducted by or on behalf of the manufacturer, Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. (China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to this type of device submission. Ground truth, in the context of an AI/ML device, typically refers to expert annotations or clinically confirmed labels on data. For a mobility scooter, "ground truth" is established by the physical testing against the measurable parameters of the ISO standards. The expertise lies in the certified labs and personnel conducting these standard tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used to resolve disagreements among human annotators or readers for AI/ML ground truth. For this device, performance is measured against objective 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
- No. An MRMC study is a clinical study design used to evaluate diagnostic imaging AI. This is a physical mobility device, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI/ML software performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is the objective, measurable criteria defined by the recognized international standards (ISO 10993 and ISO 7176 series). These standards define physical performance, safety, and biocompatibility limits.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML product developed with a "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML algorithm exists for this submission.
Summary of the study that proves the device meets the acceptance criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical performance and safety tests conducted according to a comprehensive set of international standards, primarily the ISO 7176 series (for wheelchairs and mobility scooters) and the ISO 10993 series (for biological evaluation of medical devices). Additionally, Electromagnetic Compatibility (EMC) testing was performed according to IEC 60601-1-2.
The report details that "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 results consistently demonstrated that the proposed device complies with and meets the requirements of these standards. The acceptance criteria for each test were the thresholds or specifications outlined within the respective ISO/IEC standards. The study concluded that, based on these non-clinical tests and comparisons to the predicate device, the subject device is as safe, effective, and performs as well as the legally marketed predicate device. No clinical studies were included in this submission.
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July 19, 2023
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K231472
Trade/Device Name: Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: May 22, 2023 Received: May 22, 2023
Dear Ivy Wang:
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.
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
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Indications for Use
510(k) Number (if known) K231472
Device Name Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
Indications for Use (Describe)
The mobility Scoter is a motor driven, indoor 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
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510(k) Summary
l. Applicant
Name: Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. Address: No. 68 Xinfa Road, Suzhou Industrial Park, Suzhou, Jiangsu, China Name of contact person: Chen Lezhang Telephone: +86 139 1626 7666 Email: lezhang@sweetrich.cn; gc@sweetrich.cn Date prepared: 2023-05-18 Submission Correspondent ll.
Ms. Ivy Wang
Email: zxfda@sungoglobal.com
Shanghai Sungo Management Consulting Company Limited Tel: +86-21-5881 7802
III. Device Device trade name: Mobility Scooter Model: SI SPORT, SI PLUS, MAX SPORT Regulatory Information: Classification name: Vehicle, motorized 3-wheeled Regulation class: 2 Regulation number: 21CFR 890.3800 Panel: Physical Medicine Product code: INI IV. Predicate device
K182471 Device Name: Scooter Model: KPL001 Tianjin Kepler Vehicle Industry Co. Ltd.
V. Device description
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The Mobility Scooter, Model S1 SPORT, S1 PLUS, MAX SPORT, has a base with Steel frame, two front wheels, two rear wheels, a seat, a tiller console, electric motor, electromagnetic brake, 2 rechargeable Lead-ac id 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 controller panel shape is slightly different among the three models, S1 SPORT, S1 PLUS, MAX SPORT. The S1 PLUS has a wind board on the triller, while the other two models do not have. The length of model MAX SPORT is 5cm longer than the other two models.
VI. Indication for use
The mobility scooter 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.
VII. 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 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
- . ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
- ISO 7176-3:2012 Wheelchairs Part 3: Determination of effectiveness of brakes .
- . ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs
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and scooters for determination of theoretical distance range
- . ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
- . ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
- . ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
- . ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strength
- . ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
- . ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- . ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
- . ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.
- . ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
- . ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
- . ISO 7176-16: 2012 Second edition 2012-12-01 Wheelchairs - Part 16: Resistance to ignition of postural support devices
- . ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
- . ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
- . ISO 7176-25:2013 Wheelchairs - Batteries and charqers for powered wheelchairs
- . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
VIII. Comparison with the predicate device
Table 1 General Comparison
| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| Attribute | Subject device | Predicate device | Results |
| Manufacturer | Suzhou Sweetrich VehicleIndustry Technology Co.,Ltd. | Tianjin Kepler VehicleIndustry Co. Ltd. | / |
| Proprietary name,model | Electrical ScooterSI SPORT, SI PLUS, MAXSPORT | Scooter, KPL001 | / |
| 510(k) number | K231472 | K182471 | / |
| Device classificationname | Class II | Class II | Same |
| Classificationregulations | 21 CFR 890.3800 | 21 CFR 890.3800 | Same |
| Product code | INI | INI | Same |
| Similarities | |||
| Indication for use | It is a motor driven, indoorand outdoor transportationvehicle with the intendeduse to provide mobility to adisabled or elderly personlimited to a seatedposition. | It is a motor driven, indoorand outdoor transportationvehicle with the intendeduse to provide mobility to adisabled or elderly personlimited to a seated position. | Same |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 4, including two frontwheels and two rearwheels | 4, including two pivotingcasters and two rear drivewheels | Same |
| Driving system | Direct drive on the rearwheels | Direct drive on the rearwheels | Same |
| Brake | Electromagnetic | Electromagnetic | Same |
| Time to brake | < 1 s | < 1 s | Same |
| Main frame material | Carbon Steel | Carbon Steel | Same |
| Frame style | Foldable seat, removablebattery pack, disassemblefor transport | Foldable seat, removablebattery pack, disassemblefor transport | Same |
| Battery | lead-acid 24V/12AH | lead-acid 24V/12AH | Same |
| Max loading weight | 120 kg/265 lbs approx | 120 kg/265 lbs approx | Same |
| Charger | DC 24V/2A | DC 24V/2A | Same |
| Rear wheel size/type | 8" (215 x 70 mm) Solid tire | 8" (215 x 70 mm) Solid tire | Same |
| Differences | |||
| Controller | DR50 Dynamic | PG45A | Different. |
| Maximum distance | 17 km | 15 km | Different. |
| Attributeof travel on the fullycharged battery | Subject device | Predicate device | Results |
| Overall Dimension(lengthwidthheight) | 1210662925mm (Model:S1 SPORT & S1 PLUS)1260662925mm (Model:MAX SPORT) | 1030mm*630mm * 920mm | Different |
| Brake distance | ≤1m | 1m | Different |
| Turning Radius | 1080-1200 mm | 1300 mm | Different |
| Ground clearance | 40-50 mm | 45 mm | Different |
| Maximum obstacleclimbing | 20 mm | 50 mm | Different |
| Slope grade ability | 6 ° | 0-12° | Different |
| Front wheelsize/type | 8" (215 x 70 mm) Solid tire | 7" (190 x 54 mm) Solid tire | Different |
| Max speed | 6.4 km/h | 6.6 km/h | Different |
| Motor | 24 V 300W | 24 V 180W | Different |
| Base weight (notincluding battery) | 46 kg | 50 kg | Different |
| Battery Weight | 9 kg | 10.2 kg | Different |
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Difference Analysis:
The design and technological characteristics of the subject device is basically similar to the predicate device chosen. There are minor differences between the devices including controller, travel distance, overall dimensions, front tire size, speed, turning radius, basic weight, battery weight, Brake distance, slope grade ability, obstacle climbing ability, Ground clearance and motor. There is no deleterious effect on safety and effectiveness due to the differences, and these minor differences do not influence the intended use function and use of the device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that these differences in their technological characteristics do not raise any questions as to the safety and effectiveness.
Therefore, the subject device is substantially equivalent to the Scooter (K182471).
Table 2 Safety comparison
| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| Biocompatibility | All user directly contactingmaterials are compliance with | All user directly contactingmaterials are compliance | S.E. |
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| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| ISO10993-5,ISO10993-10, ISO 10993-23requirements. | with ISO10993-5 andISO10993-10 requirements. | ||
| 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
| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| ISO7176-1 | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | S.E. |
| ISO7176-2 | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification | S.E. |
| ISO7176-3 | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its 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. | S.E. |
| ISO7176-4 | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its 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. | S.E. |
| ISO7176-5 | The dimensions, mass has been determined after the testing according to the ISO 7176-5. | The dimensions, mass has been determined after the testing according to the ISO 7176-5. | S.E. |
| ISO7176-6 | The maximum speed, acceleration and deceleration of scooter has been determined after the testing according to the ISO 7176-6 | The maximum speed, acceleration and deceleration of scooter has been determined after the testing according to the ISO 7176-6 | 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 | All test results meet the | S.E. |
| Attribute | Subject device | Predicate device | Results |
| ISO7176-9 | requirements in Clause 4 of ISO 7176-8The 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 | requirements in Clause 4 of ISO 7176-8The 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 meets the requirements of ISO 7176-16. | The performance of resistance to ignition meets the requirements of ISO 7176-16. | S.E. |
| ISO7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | S.E. |
| ISO7176-22 | All performed tests are set up as requirements of ISO 7176-22 | All performed tests are set up as requirements of ISO 7176-22 | S.E. |
| ISO7176-25 | The performance of batteries and charger of device meet the 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 | S.E. |
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IX. Summary of clinical testing
No clinical study is included in this submission.
X. Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device 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).