Mobility Scooter (Models: W3431Q, W3431R)

K222507 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · INI · Feb 28, 2023 · Physical Medicine

Device Facts

• Record ID: K222507
• Device Name: Mobility Scooter (Models: W3431Q, W3431R)
• Applicant: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
• Product Code: INI · Physical Medicine
• Decision Date: Feb 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Motor-driven mobility scooter (Models W3431Q, W3431R) for indoor/outdoor use by disabled or elderly individuals. Features steel frame, four wheels, seat, tiller console, electric motor, and electromagnetic brakes. Rider controls speed and direction via throttle lever and handle on tiller console. Electromagnetic brake engages automatically when not in use. Powered by two 12V lead-acid batteries with off-board charger. Device provides seated mobility; intended for flat road operation. No remote control functionality. Operator is the patient.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 7176 series (stability, brakes, energy consumption, dimensions, strength, climatic, obstacle-climbing, power/control systems, EMC, batteries) and ISO 10993 (biocompatibility) demonstrated safety and performance equivalent to the predicate.

Technological Characteristics

Steel frame; 24V electric motor; electromagnetic braking; two 12V lead-acid batteries; off-board charger. Dimensions: 1020mm x 500mm x 840mm. Max speed 6 km/h. Complies with ISO 7176 series (stability, strength, EMC, etc.) and ISO 10993-5/10 for biocompatibility.

Indications for Use

Indicated for disabled or elderly persons limited to a seated position requiring indoor and outdoor mobility assistance.

Regulatory Classification

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.

Predicate Devices

• Scooter Model W3468A (K220206)

Submission Summary (Full Text)

{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 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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# 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)

#### 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."

{3}------------------------------------------------

# 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: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

#### 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

{4}------------------------------------------------

#### 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

{5}------------------------------------------------

#### 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 of<br>Comparison | Predicate Device (K220206) | Subject Device | Remark |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Manufacturer | Zhejiang Innuovo Rehabilitation<br>Devices Co.,Ltd | Zhejiang Innuovo Rehabilitation<br>Devices Co.,Ltd | Same |
| Common or<br>Usual name | Scooter | Scooter | Same |
| Model(s) | W3468A | W3431Q, W3431R | -- |
| Indications<br>for use | It is a motor driven, indoor and<br>outdoor transportation vehicle with the<br>intended use to provide mobility to a<br>disabled or elderly person limited to a<br>seated position. | It is a motor driven, indoor and<br>outdoor transportation vehicle with the<br>intended use to provide mobility to a<br>disabled or elderly person limited to a<br>seated position. | S.E. |
| Overall<br>dimension | 1075 mm x 500 mm x 920 mm | 1020 mm x 500 mm x 840 mm | Similar |
| Frame<br>Material | Steel | Steel | S.E. |
| Frame style | Foldable seat, removable battery pack,<br>disassemble for transport | Foldable seat, removable battery pack,<br>disassemble for transport | S.E. |
| Front wheel<br>size | 200 x 50 mm | 190 x 55 mm | Analysis |
| Front Wheels<br>Quantity | 2 | 2 | S.E. |
| Rear wheel<br>size | 200 x 50 mm | 190 x 55 mm | Analysis |
| Rear Wheels<br>Quantity | 2 | 2 | S.E. |
| Ground<br>clearance | 100mm(3.9") | 45 mm | Analysis |
| Max<br>Loading( on<br>level 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 Grade<br>Ability | 9 degree | 9 degree | S.E. |
| Travel<br>Distance | 14km / 9 Miles (12Ah) | 15 km/9.32 Miles | S.E. |
| Arm Rests<br>(Distance<br>between<br>armrests) | 44 cm | 44-56 cm | Analysis |
| Controller | PG45A | 45A | Similar |
| Time to<br>brake | 0.7-1s | < 1 s | S.E. |
| Brake<br>Distance-<br>Normal<br>operation<br>(Horizontal-<br>Forwa rd-<br>Max speed) | ≤1.5m | ≤1.5m | S.E. |
| Battery<br>weight | Battery Pack (12Ah) – 9kg (20lb)<br>Battery Pack (20Ah) – 14kg (31lb) | 8.8kg | Analysis |
| Base weight<br>(not<br>including<br>battery) | 45kg | 42kg | Analysis |
| Operating<br>surface &<br>environment | Indoor use and restricted outdoor use<br>on pavements or paved footpaths only. | Indoor use and restricted outdoor use<br>on pavements or paved footpaths only. | S.E. |
| Remote<br>control | None | None | S.E. |

{6}------------------------------------------------

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China

{7}------------------------------------------------

# 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 contacting<br>materials are compliance with<br>ISO10993-5 and<br>ISO10993-10 requirements. | All user directly contacting<br>materials are compliance with<br>ISO10993-5 and<br>ISO10993-10 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 been<br>determined after the testing according<br>to the ISO 7176-1, and test results<br>meet its design specification. | The Static stability has been<br>determined after the testing according<br>to the ISO 7176-1, and test results meet<br>its design specification. | S.E. |
| ISO7176-2 | The dynamic stability has been<br>determined after the testing according<br>to the ISO 7176-2, and test results<br>meet its design specification. | The dynamic stability has been<br>determined after the testing according<br>to the ISO 7176-2, and test results meet<br>its design specification. | S.E. |
| ISO7176-3 | The effectiveness of brakes has been<br>determined after the testing according<br>to the ISO 7176-3, and test results<br>meet its design specification. | The effectiveness of brakes has been<br>determined after the testing according<br>to the ISO 7176-3, and test results meet<br>its design specification. | S.E. |
| ISO7176-4 | The theoretical distance range has<br>been determined after the testing<br>according to the ISO 7176-4, and test<br>results meet its design specification. | The theoretical distance range has<br>been determined after the testing<br>according to the ISO 7176-4, and test<br>results meet its design specification. | S.E. |
| ISO7176-5 | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-5, | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-5, | S.E. |
| ISO7176-6 | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-5, | The dimensions, mass has been<br>determined after the testing according<br>to the ISO 7176-5, | S.E. |
| Zhejiang Innuovo Rehabilitation Devices Co.,Ltd<br>No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China | | | |
| ISO7176-7 | The seating and wheel dimensions<br>has been determined after the testing<br>according to the ISO 7176-7. | The seating and wheel dimensions<br>has been determined after the testing<br>according to the ISO 7176-7. | S.E. |
| ISO7176-8 | All test results meet the<br>requirements in Clause 4 of ISO<br>7176-8 | All test results meet the<br>requirements in Clause 4 of ISO<br>7176-8 | S.E. |
| ISO7176-9 | The test results shown that the device<br>under tests could continue to<br>function according to manufacturer's<br>specification after being subjected to<br>each of the tests specified in Clause 8<br>of ISO 7176-9 | The test results shown that the device<br>under tests could continue to function<br>according to manufacturer's<br>specification after being subjected to<br>each of the tests specified in Clause 8<br>of ISO 7176-9 | S.E. |
| ISO7176-10 | The obstacle-climbing ability of<br>device has been determined after the<br>testing according to the ISO 7176-<br>10, | The obstacle-climbing ability of<br>device has been determined after the<br>testing according to the ISO 7176-<br>10, | S.E. |
| ISO7176-11 | The test dummies used in the testing<br>of ISO 7176 series are meet the<br>requirements of ISO 7176-11 | The test dummies used in the testing<br>of ISO 7176 series are meet the<br>requirements of ISO 7176-11 | S.E. |
| ISO7176-13 | The coefficient of friction of test<br>surfaces has<br>been determined, which could be used<br>in other 7176 series tests involved | The coefficient of friction of test<br>surfaces has<br>been determined, which could be used<br>in other 7176 series tests involved | S.E. |
| ISO7176-14 | All test results meet the<br>requirements in Clause 7, 8, 9, 10,<br>11, 12, 13, 14, 15, 17 of ISO 7176-<br>14 | All test results meet the<br>requirements in Clause 7, 8, 9, 10,<br>11, 12, 13, 14, 15, 17 of ISO 7176-<br>14 | S.E. |
| ISO7176-15 | The test results shown that<br>information disclosure,<br>documentation and labelling of<br>device meet the requirements of<br>ISO 7176-15 | The test results shown that<br>information disclosure,<br>documentation and labelling of<br>device meet the requirements of ISO<br>7176-15 | S.E. |
| ISO7176-16 | The performance of resistance to<br>ignition meet the requirements of<br>ISO 7176-16 | The performance of resistance to<br>ignition meet the requirements of<br>ISO 7176-16 | S.E. |
| ISO 7176-21 | The EMC performance results meet<br>the requirements of ISO 7176-21 | The EMC performance results meet the<br>requirements of ISO 7176-21 | S.E. |
| ISO7176-25 | The performance of batteries and<br>charger of device meet the<br>Requirements in Clause 5 and 6 of | The performance of batteries and<br>charger of device meet the<br>Requirements in Clause 5 and 6 of ISO | S.E. |

{8}------------------------------------------------

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

{9}------------------------------------------------

### 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.