(121 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components and standard safety/performance testing for mobility scooters. There is no mention of AI/ML terms, image processing, or data sets for training/testing algorithms.
No
The device is described as a transportation vehicle to provide mobility, which is generally considered a mobility aid and not a therapeutic device in the sense of treating a disease or condition. While it assists disabled or elderly persons, its primary function is transport rather than therapy.
No
The device is described as a mobility scooter intended for transportation, not for diagnosing medical conditions or diseases.
No
The device description clearly outlines physical hardware components such as a steel frame, wheels, seat, tiller console, electromagnetic brake, and batteries. It is a physical transportation vehicle, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to a disabled or elderly person. This is a physical function, not a diagnostic one.
- Device Description: The description details a transportation vehicle with mechanical and electrical components for movement and control. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or states of health.
- Performance Studies: The performance studies focus on the physical and functional aspects of the scooter (stability, braking, speed, strength, etc.), not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This mobility scooter does not fit that definition.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The Mobility Scooter, Model: W3431, has a base with Steal frame, two front 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
disabled or elderly person
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, ISO 10993-10: 2010, ISO 7176-1: 2014, ISO 7176-2:2017, ISO 7176-3: 2012, ISO 7176-4, Third edition 2008-10-01, ISO 7176-5, Second edition 2008-06-01, ISO 7176-6: 2018, ISO 7176-7, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2012, ISO 7176-13, First edition 1989-08-01, ISO 7176-14:2008, ISO 7176-15:1996, ISO 16840-10:2021, ISO 7176-21:2009, ISO 7176-25:2013.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 2, 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: K240012
Trade/Device Name: Mobility Scooter (W3431) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: April 17, 2024 Received: April 17, 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.
1
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,
Julia E. Slocomb 2024.05.02 -5 18:48:09 -04'00'
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices
2
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
510(k) Number (if known) K240012
Device Name Mobility Scooter (W3431)
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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4
510(K) Summary K240012
Document Prepared Date: 2024/04/12
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: W3431
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: K231428 Classification Name: Motorized three-wheeled vehicle Regulation Number: 890.3800 Device Name: Mobility Scooter Model: W3431D
5
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, Model: W3431, has a base with Steal frame, two front 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 ハ Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And A Skin Sensitization
-
ISO 7176-1: 2014, Wheelchairs - Part 1: Determination of static stability
-
ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of Powered Wheelchairs
- ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes >
-
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
- ISO 7176-8:2014, Wheelchairs Part 8: Requirements and test methods for static, impact and ハ 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. >
- A 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
6
-
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
| Elements of
| Comparison | Subject Device | Predicate Device (K231428) | Remark |
|---|---|---|---|
| Manufacturer | Zhejiang Innuovo Rehabilitation | ||
| Devices Co.,Ltd | Zhejiang Innuovo Rehabilitation | ||
| Devices Co.,Ltd | Same | ||
| Common or | |||
| Usual name | Scooter | Scooter | Same |
| Model(s) | W3431 | W3431D | -- |
| Indications for | |||
| use | 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. | 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. | S.E. | ||
| Overall | |||
| dimension | 1020 mm x 500 mm x 840 mm | 1020 mm x 500 mm x 840 mm | S.E. |
| Frame Material | 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 wheel | |||
| size | 190 x 55 mm | 190 x 55 mm | S.E. |
| Front Wheels | |||
| Quantity | 2 | 2 | S.E. |
| Rear wheel size | 190 x 55 mm | 190 x 55 mm | S.E. |
| Rear Wheels | |||
| Quantity | 2 | 2 | S.E. |
| Ground | |||
| clearance | 45 mm | 45 mm | S.E. |
| Max | |||
| Loading( on | |||
| level ground) | 120kg | 120kg | S.E. |
| Turn Radius | 1650mm | 1650mm | S.E. |
| Motor output | LINIX 24 V 180W | 24 V 180W | Analysis |
| Drive System | Rear Wheel Drive | Rear Wheel Drive | S.E. |
| No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang, China | |||
| 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 | 6 km/h | 6 km/h | S.E. |
| Slope Grade | |||
| Ability | 9 degree | 9 degree | S.E. |
| Travel | |||
| Distance | 15 km/9.32 Miles | 15 km/9.32 Miles | S.E. |
| Arm Rests | |||
| (Distance | |||
| between | |||
| armrests) | 44-56 cm | 44-56 cm | S.E. |
| Controller | PG45A | PG45A | S.E. |
| Time to brake | 0.7-1s | 0.7-1s | S.E. |
| Brake | |||
| Distance- | |||
| Normal | |||
| operation | |||
| (Horizontal- | |||
| Forward- Max | |||
| speed) | ≤1.5m | ≤1.5m | S.E. |
| Battery weight | 8.8kg | 8.8kg | S.E. |
| Base weight | |||
| (not including | |||
| battery) | 42kg | 42kg | S.E. |
| Operating | |||
| surface & | |||
| environment | Indoor use and restricted outdoor use on | ||
| pavements or paved footpaths only. | Indoor use and restricted outdoor use on | ||
| pavements or paved footpaths only. | S.E. | ||
| Remote control | None | None | S.E. |
Table 1 General Comparison
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Zhejiang Innuovo Rehabilitation Devices Co.,Ltd No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China
I. Difference analysis
The design and technological characteristics of the proposed device scooter is identical to the predicate device. There are minor differences between the drand/suppliler of battery and motor. and the proposed device uses Long Way Lead-acid Batteries and LINIX 180W Motor.
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 (K231428).
The Mobility Scooter Model W3431 in its final finished form is identical to the Mobility Scooter Model W3431D in formulation, processing, sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)
Table 2 Safety comparison
8
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China
| Item | Proposed Device | Predicate Devices | Results |
|---|---|---|---|
| Biocompatibility | All user directly contacting | ||
| materials are compliance with | |||
| ISO10993-5 and | |||
| ISO10993-10 requirements. | All user directly contacting | ||
| materials are compliance with | |||
| ISO10993-5 and | |||
| ISO10993-10 requirements. | S.E. | ||
| EMC | ISO7176-21 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 3 Safety comparison
| Item | Proposed Device | Predicate Devices | 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 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. | ||
| ISO7176-7 | 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 | |||
| 7176-8 | All test results meet the | ||
| requirements in Clause 4 of ISO | |||
| 7176-8 | S.E. | ||
| 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 | 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 | S.E. | ||
| No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang, China | |||
| of ISO 7176-9 | of ISO 7176-9 | ||
| 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/ | |||
| ISO 16840- | |||
| 10:2021 | The performance of resistance to ignition meet the requirements of ISO 16840-10:2021 | The performance of resistance to ignition meet the requirements of ISO 7176-16 | S.E. |
| ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | S.E. |
| ISO7176-25 | 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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Zhejiang Innuovo Rehabilitation Devices Co.,Ltd No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Mobility scooter, model W3431, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K231428.