(60 days)
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.
This 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. The Mobility Scooter, Model N3473, has a base with magnesium alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger, a remote control switch. 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 (N3473), a medical device. It does not contain information about an AI/ML-driven medical device.
Therefore, I cannot provide information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes, data provenance, number of experts, adjudication methods for training or test sets in the context of AI/ML.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used for AI/ML.
- How ground truth for training sets was established for AI/ML.
The document discusses the non-clinical testing performed for a physical device (mobility scooter) to demonstrate its substantial equivalence to a predicate device. This testing primarily involves adherence to ISO 7176 series standards related to wheelchairs and scooters, covering aspects like stability, brakes, speed, dimensions, strength, climatic tests, obstacle climbing, power/control systems, and electromagnetic compatibility.
Here's what can be extracted from the document regarding the mobility scooter's acceptance criteria and study:
1. Acceptance Criteria and Reported Device Performance (Non-AI Device)
The general acceptance criteria are that the subject device's performance meets the relevant ISO standards and exhibits no deleterious effect on safety and effectiveness compared to the predicate device, despite minor differences. The document asserts that "All test results meet the requirements" of the specified ISO standards for the subject device.
Here's a table based on the explicit comparisons provided, specifically focusing on measurable performance attributes mentioned in the "Comparison with the predicate device" section. While a direct "acceptance criterion" value isn't always given, the "Result" column implies acceptance if "Same" or if the difference is deemed non-deleterious after testing.
| Acceptance Criterion (implicitly met by matching predicate or standard) | Reported Subject Device Performance | Predicate Device Performance | Result (from document) | Notes |
|---|---|---|---|---|
| Time to brake | < 1 s | < 1 s | Same | Conforms to ISO 7176-3 |
| Max loading weight | 120 kg | 120 kg | Same | |
| Brake distance | 1.1 m | 1.1 m | Same | |
| Dynamic Stability (uphill/downhill pitch) | 6 ° | 6 ° | Same | Conforms to ISO 7176-2 |
| Max speed | 6 km/h | 6 km/h | Same | Conforms to ISO 7176-6 |
| Maximum distance of travel on fully charged battery | 17 km | 20 km | Different | Deemed not deleterious; conforms to ISO 7176-4 |
| Turning Radius | 1350 mm | 1200 mm | Different | Deemed not deleterious |
| Ground clearance | 65 mm | 50 mm | Different | Deemed not deleterious |
| Maximum obstacle climbing | 15 mm | 60 mm | Different | Deemed not deleterious; tested per ISO 7176-10 |
| Biocompatibility | Meets ISO 10993-5, ISO 10993-10 | Meets ISO 10993-5, ISO 10993-10 | S.E. | For user directly contacting materials |
| EMC | Meets ISO 7176-21 & IEC 60601-1-2 | Meets ISO 7176-21 | S.E. | Subject device tested to an additional standard (IEC 60601-1-2:2020) |
| Performance (General) | Meets ISO 7176 series | Meets ISO 7176 series | S.E. | Numerous specific ISO tests listed (7176-1, -2, -3, etc.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of units tested. This document refers to "non-clinical tests" and "test results" in a general sense, implying performance testing of the device itself rather than a dataset of patient cases. It's typical for device performance testing to use a small number of production or pre-production units.
- Data Provenance: The tests are performed by the manufacturer/sponsor (Zhejiang Innuovo Rehabilitation Devices Co., Ltd.) or a contracted testing facility, to demonstrate compliance with international standards (ISO, IEC). The location of the testing facility is not explicitly stated, but the manufacturer is based in China. The data would be prospective, as it's the result of specific tests conducted on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is not a study involving interpretation of medical images or patient data by human experts for AI/ML ground truth. The "ground truth" for this physical device is established by objective measurements and standardized test procedures defined by the ISO 7176 series and IEC 60601-1-2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective human interpretations, typically in clinical studies or AI algorithm validation against human consensus. For engineering performance tests like those conducted for a mobility scooter, compliance is determined by whether the measured parameters fall within the limits set by the relevant standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML medical device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML medical device. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is established by objective measurements against the quantitative and qualitative requirements of the ISO 7176 series and IEC 60601-1-2 standards. Examples include measured brake distance, speed, static stability angle, and material compliance (e.g., biocompatibility testing per ISO 10993).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML medical device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML medical device.
In summary, the provided document details the regulatory submission for a physical medical device (mobility scooter) based on demonstrating substantial equivalence through non-clinical performance testing against established international standards, not an AI/ML-driven device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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 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.
October 9, 2024
Zhejiang Innuovo Rehabilitation Devices Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, Dongfang Building, 1500# Century Ave Shanghai. 200122 China
Re: K242387
Trade/Device Name: Mobility Scooter (N3473) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 12, 2024 Received: August 12, 2024
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 (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.
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"
{1}------------------------------------------------
(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
{2}------------------------------------------------
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
Mobility Scooter
Indications for Use (Describe)
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.
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."
{4}------------------------------------------------
510(k) Summary
K242387
l. Applicant
Name: Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang, China
Name of contact person: Grace Li
Tel: +86 15924234767
Fax: +86-579-89327232
Email: Lss@kf-innuovo.com
Date prepared: 2024-10-04
II. Submission Correspondent
Ms. Ivy Wang
Shanghai Sungo Management Consulting Co., Ltd.
Tel: +86-21-5881 7802
Email: haiyu.wang@sungoglobal.com
III. Device
Device trade name: Mobility Scooter
Model: N3473
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
K201196 Device Name: Scooter Model: FDB01
{5}------------------------------------------------
Nanjing Jin Bai He Medical Apparatus Co. Ltd.
V. Device description
This 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. The Mobility Scooter, Model N3473, has a base with magnesium alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger, a remote control switch. 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.
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. Comparison with the predicate device
| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| Manufacturer | ZhejiangRehabilitationCo., Ltd. | Innuovo Nanjing Jin Bai He MedicalDevices Apparatus Co. Ltd. | / |
| Proprietary name,model | Mobility ScooterN3473 | Scooter, FDB01 | / |
| 510(k) number | K242387 | K201196 | / |
| 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 | The mobility scooter is amotor driven, indoor andoutdoor transportationvehicle with the intended | It is a motor driven, indoorand outdoor transportationvehicle with the intendeduse to provide mobility to a | Same |
| Table 1 General Comparison | |||
|---|---|---|---|
| Attribute | Subject device | Predicate device | Results |
| use to provide mobility to adisabled or elderly personlimited to a seated position. | use to provide mobility to adisabled or elderly personlimited to a seated position. | use 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 |
| Controller | PG45A | PG45A | Same |
| Frame style | Foldable seat, removablebattery pack, disassemblefor transport | Foldable seat, removablebattery pack, disassemblefor transport | Same |
| Folding mechanism | Seat can be folded; batterycan be dismantled ; Theframe can be folded backand forth. | Seat can be folded; batterycan be dismantled ; Theframe can be folded backand forth. | Same |
| Setting Design | One-click folding intelligentelectric scooter, with asensitive remote control,gently press, the scooterautomatically completedfolding contraction, foldingvolume small,electromagnetic automaticbrake, the overall simpledesign, convenient andpractical, Travel does nothave to consume physicalforce to do folding, poorphysical strength and theelderly the best walkingtool. | One-click folding intelligentelectric scooter, with asensitive remote control,gently press, the scooterautomatically completedfolding contraction, foldingvolume small,electromagnetic automaticbrake, the overall simpledesign, convenient andpractical, Travel does nothave to consume physicalforce to do folding, poorphysical strength and theelderly the best walkingtool. | Same |
| Battery | Lithium battery 24V/12AH | Lithium battery 24V/6AH*2 | Same |
| Max loading weight | 120 kg | 120 kg | Same |
| Brake distance | 1.1m | 1.1m | Same |
| Attribute | Subject device | Predicate device | Results |
| Dynamic Stability | 6 ° | 6 ° | Same |
| Max speed | 6 km/h | 6 km/h | Same |
| Differences | |||
| Main frame material | Magnesium alloy | Aluminum alloy | Different |
| Maximum distanceof travel on the fullycharged battery | 17 km | 20km | Different |
| Overall Dimension(lengthwidthheight) | 970580 950mm | 1050mm*550mm * 870mm | Different |
| Turning Radius | 1350 mm | 1200 mm | Different |
| Ground clearance | 65 mm | 50mm | Different |
| Maximum obstacleclimbing | 15 mm | 60 mm | Different |
| Front wheelsize/type | 7" PU solid tire | 7" Solid tire | Same |
| Rear wheel size/type | 8" PU solid tire | 8" Solid tire | Same |
| Motor | 24 V 150W | 24 V 180W | Different |
| Charger | Input:100-240Vac,50-60Hz, 1.1AOutput: 24V/2A | Input:100-240Vac,50-60Hz, 1.2-0.5AOutput: 24V/2A | Different |
{6}------------------------------------------------
{7}------------------------------------------------
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 frame material, travel distance, overall dimensions, turning radius, obstacle climbing ability, Ground clearance, charger and motor specification. 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 (K201196).
| 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. |
{8}------------------------------------------------
| Attribute | Subject device | Predicate device | Results |
|---|---|---|---|
| ISO10993-5, ISO10993-10, requirements. | with ISO10993-5 and ISO10993-10 requirements. | ||
| EMC | ISO7176-21 & 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 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 requirements in Clause 4 of ISO | All test results meet the requirements in Clause 4 of ISO | S.E. |
| Attribute | Subject device | Predicate device | Results |
| 7176-8 | 7176-8 | ||
| ISO7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | S.E. |
| ISO7176-10 | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10. | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10. | S.E. |
| ISO7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11. | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11. | S.E. |
| ISO7176-13 | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | S.E. |
| ISO7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | S.E. |
| ISO7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | S.E. |
| ISO 7176-16/ISO 16840-10 | The performance of resistance to ignition meets the requirements of ISO 16840-10. | The performance of resistance to ignition meets the requirements of ISO 7176-16. | S.E. |
| ISO7176-21/IEC60601-1-2 | The EMC performance results meet the requirements of ISO 7176-21 & IEC 60601-1-2 | 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. |
{9}------------------------------------------------
VIII. Non-Clinical Test Conclusion
{10}------------------------------------------------
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 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 ● 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 fatigue 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 7176-14:2022 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 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 .
{11}------------------------------------------------
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 chargers for powered wheelchairs
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020. .
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 K201196.
§ 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).