eFOLDi Scooter, Lite

K223492 · Suntech UK , Ltd. · INI · Feb 22, 2023 · Physical Medicine

Device Facts

• Record ID: K223492
• Device Name: eFOLDi Scooter, Lite
• Applicant: Suntech UK , Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Feb 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Indications for Use

The "eFOLDI Scooter, Lite" 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.

Device Story

eFOLDI Scooter, Lite is a foldable, motor-driven, three-wheeled electric scooter for indoor/outdoor mobility. Rider controls speed and direction via throttle lever and speed control handle on a tiller console. Powered by 24V 180W motor and rechargeable Lithium-Ion batteries; features electromagnetic braking system that engages automatically when not in use. Constructed with magnesium alloy frame, aluminum alloy wheels, and ignition-resistant polyurethane artificial leather upholstery. Operated by the user; provides mobility for individuals with walking limitations. Output is physical transport of the user. Benefits include increased mobility and independence for elderly or disabled users.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified against ISO 7176 series (parts 1-10, 14, 16) for stability, braking, energy consumption, dimensions, speed, strength, climatic resistance, and obstacle climbing. Biocompatibility verified per ISO 10993-1.

Technological Characteristics

Magnesium alloy frame; aluminum alloy wheels; polyurethane artificial leather upholstery (ignition resistant). 24V 180W DC brush motor; Lithium-Ion battery. Electromagnetic braking system. Dimensions: 117x55x95 cm (unfolded), 65x55x37 cm (folded). Connectivity: None. Sterilization: N/A. Controller: MM32SPIN05X. Standards: ISO 7176-1 through 16, ISO 10993-1.

Indications for Use

Indicated for disabled or elderly persons limited to a seated position requiring 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: FDB01) (K201196)

Submission Summary (Full Text)

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February 22, 2023

SunTech UK Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436

Re: K223492

Trade/Device Name: eFOLDi Scooter, Lite Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: January 12, 2023 Received: February 13, 2023

Dear Charles Shen:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

| Julia E. | Julia E. Slocomb -S |
|------------|--------------------------------|
| Slocomb -S | 2023.02.22 13:36:19<br>-05'00' |

for Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K223492

Device Name eFOLDi Scooter, Lite

Indications for Use (Describe)

The "eFOLDI Scooter, Lite" 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)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) Number: K223492

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92

#### Submitter Information 1.0

SunTech UK Ltd. 25 Ormside Way, Holmethorpe Industrial Estate, Redhill, Surrey, RH1 2LW, UK Tel : [phone] Submitter's FDA Registration Number: N/A

## Submission Correspondent

Image /page/3/Picture/6 description: The image shows a logo for a medical company. The logo features a large blue "M" shape, with the Chinese characters "曼度医械" in orange above it. A blue arc is positioned above the characters, completing the logo's design. The logo appears to be for a company named Mandu Medical Equipment.

Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: [phone] Email: [e-mail]

## Date of Summary: November 16, 2022

#### 2.0 Device Information

| Proprietary Name: | eFOLDi Scooter, Lite |
|------------------------|------------------------------|
| Common Name: | Electric Scooter |
| Classification Name: | Vehicle, Motorized 3-Wheeled |
| Device Classification: | II |
| Regulation Number: | 21 CFR 890.3800 |
| Product Code: | INI |
| Panel: | Physical Medicine |

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#### 3.0 Predicate Device Information:

| Manufacturer: | Nanjing Jin Bai He Medical Apparatus Co., Ltd. |
|---------------|------------------------------------------------|
| Product Name: | Scooter (Model: FDB01) |
| 510(K) #: | K201196 |

#### 4.0 Device description:

The eFoldi Scooter. Lite is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with metal alloy frame, one front wheels, two rear wheels, a seat, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, 2 rechargeable Lithium-Ion Battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control 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 or slopes less than 6 degrees. The scooter is foldable.

The scooter has a physical dimension of 117 (depth) x 55 (width) x 95 (height) cm, with the seat itself has a dimension of 36 (depth) x 36 (width) x 50 (height) cm. The footrest is 10 cm in height. The scooter is foldable, and the folded dimension is 65 (Long) x 55 (width) x 37 (height) cm.

The device has a weight capacity of 120 kilograms, and weighs about17 kilograms with battery (15 kilograms without battery). The color is dark grey.

The scooter consists of three wheels, a mechanical main frame, seat, handle, and Polyurethane artificial leather upholstery that is ignition resistant.

The frame of the scooter is made of magnesium alloy.

The scooter uses aluminum alloy wheels and has a diameter of 25.4 cm (10 inch) and the front wheel has a diameter of 20.3 cm (8 inch). Both front wheels use solid tires and the back wheel is pneumatic tire.

The scooter has a motor of 24V and 180 Watt, which allows a maximum speed of 6 kilometers per hour, and maximum travel range of 15 kilometers. It brakes by electromagnetic effect on the front wheel.

The wheel lock is in the form of electromagnetic force to apply mechanical resistance to the front wheels to force stop.

#### 5.0 Indications for Use:

The "eFOLDI Scooter, Lite" 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. 510(k) Summary

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#### 6.0 Comparison to Predicate Devices

The "eFOLDi Scooter, Lite" manufactured by "SUNTECH UK LTD" is compared with the following Predicate Device in terms of intended use, design, material, specifications, and performance.

- K201196, "Scooter (Model: FDB01)", manufactured by "Nanjing Jin Bai He Medical (1) Apparatus Co., Ltd."
The following table shows similarities and differences of use, design, and material between our devices and the predicate device.

| Characteristic | Subject Device | Predicate Device (K201196) | Substantial<br>Equivalence |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Indication for use | It is a motor driven, indoor and<br>outdoor transportation vehicle with<br>the intended use to provide mobility<br>to a disabled or elderly person limited<br>to a seated position. | It is a motor driven, indoor and<br>outdoor transportation vehicle with<br>the intended use to provide mobility<br>to a disabled or elderly person<br>limited to a seated position. | S.E. |
| Overall Dimensions | 1170 x 550 x 950 mm | 1050 x 550 x 870 mm | Similar |
| Folded Dimensions | 370 x 550 x 670 mm | 480 x 550 x 790 mm | Similar |
| Weight with batteries | 16.7 KG | 29 KG | Similar |
| Weight without<br>batteries | 15 KG | 24.2 KG | Similar |
| Controller | MM32SPIN05X from Mindmotion | British PG Controller PG45A | Different |
| Drive Style (e.g., rear,<br>mid, front) | Front-wheel drive | Rear-wheel drive | Different |
| Motor Type | 24 DC brush differential front axle | 24V DC brush differential rear axle | S.E. |
| Motor Output | 24V 180W | 24V 180W | S.E. |
| Batteries | Lithium battery | Lithium battery | S.E. |
| Range per Charge | 6 hours | 6 hours | S.E. |
| Charger Type (On-<br>board/Off-<br>board/Carry- on) | Carry-on | Carry-on | S.E. |
| Charger Input /<br>Output Power | 100-240VAC 50/60Hz 2A | 100-240VAC 50/60Hz 1.2.-0.5A | Similar |
| Actuator | Intelligent, Regenerative and<br>Electromagnetic brake system | Intelligent, Regenerative and<br>Electromagnetic brake system | S.E. |

## Table5.1: Comparison of Intended Use, Design, and Material

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| Brake | Electromagnetic brake | Electromagnetic brake | S.E. |
|--------------------------------------|-----------------------------------------|-----------------------------------------|--------------|
| Minimum braking<br>distance and time | 0.7 meter for the speed of 6km/h<br><1s | 1.1 meter for the speed of 6km/h<br><1s | S.E.(Note 1) |
| Wheel Lock (type) | electromagnetic brake | electromagnetic brake | S.E. |
| Max speed Forward | 6 km/h | 6 km/h | S.E. |
| Max speed Reverse | 2 km/h | 3 km/h | S.E.(Note 1) |
| Rear Wheels Size | 10 inches | 8 inches | Similar |
| Front Tire Size | 8 inches | 7 inches | Similar |
| Tire Pressure (if<br>pneumatic) | N/A | NA | S.E. |
| Anti-tip Wheels | N/A | 2.5 inches | Different. |
| Maximum Occupant<br>Mass | 120 KG | 120 KG | S.E |
| Curb Climbing ability | 40 mm | 60 mm | Different |
| Ground clearance | 100 mm | 50 mm | Different |
| Minimum Turning<br>Radius | 1.97 m | 1.2m | Different |
| Maximum Incline | ≥ 15° for all directions | ≥ 15° for all directions | S.E. |
| Footplates | Aluminum | ABS plastics | Different |
| Back Upholstery | Leather package | Leather package | S.E |
| Operating surface &<br>environment | Indoor and outdoor use | Indoor and outdoor use | S.E. |

The minor differences between the subject device and predicate device do not raise any concerns in terms of safety and effectiveness.

#### 7.0 Non-Clinical Study Summary

Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

| Tests | Standard |
|------------------|-----------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | All user directly contacting materials are compliance with<br>ISO10993-1 requirements. |
| EMC | ISO7176-21: Wheelchairs - Part 21: Requirements and test<br>methods for electromagnetic compatibility of electrically |

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| | powered wheelchairs and scooters, and battery chargers |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance | ISO 7176-1: Wheelchairs - Part 1: Determination of static<br>stability |
| | ISO 7176-2: Wheelchairs - Part 2:Determination of dynamic<br>stability of electrically powered wheelchairs |
| | ISO 7176-3: Wheelchairs - Part 3: Determination of<br>effectiveness of brakes |
| | ISO 7176-4: Wheelchairs - Part 4: Energy consumption of<br>electric wheelchairs and scooters for determination of<br>theoretical distance range |
| | ISO 7176-5: Wheelchairs - Part 5: Determination of overall<br>dimensions, mass and manoeuvring space |
| | ISO 7176-6: Wheelchairs - Part 6: Determination of maximum<br>speed, acceleration and deceleration of electric wheelchairs |
| | ISO 7176-7: Wheelchairs - Part 7: Measurement of seating and<br>wheel dimensions |
| | ISO 7176-8: Wheelchairs - Part 8: Requirements and test<br>methods for static, impact and fatigue strengths |
| | ISO 7176-9: Wheelchairs - Part 9: Climatic tests for electric<br>wheelchairs |
| | ISO 7176-10: Wheelchairs - Part 10: Determination of<br>obstacle-climbing ability of electrically powered wheelchairs |
| | ISO 7176-14: Wheelchairs - Part 14: Power and control<br>systems for electrically powered wheelchairs and scooters -<br>Requirements and test methods |
| | ISO 7176-16: Wheelchairs - Part 16: Resistance to ignition of<br>postural support devices |

#### 8.0 Clinical Study Summary

Clinical study is not performed for this product.

#### 9.0 Conclusion

The conclusions drawn from the nonclinical tests that demonstrate is that the subject device is as safe, as effective, and performs as well as the legally marketed device.