(93 days)
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.
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.
This document describes the regulatory approval for the eFOLDi Scooter, Lite, a motorized three-wheeled vehicle. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a novel AI device or diagnostic.
Therefore, many of the requested items (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment for AI models) are not applicable to this type of regulatory submission for a physical medical device like an electric scooter. The "acceptance criteria" here are defined by compliance with recognized standards and a comparison against a predicate device.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Predicate Comparison):
The acceptance criteria for this device are primarily demonstrated through compliance with recognized international standards (ISO 7176 series for wheelchairs and scooters, ISO 10993-1 for biocompatibility, and ISO 7176-21 for EMC) and by showing that any differences from the predicate device do not raise new safety or effectiveness concerns.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance / Compliance |
|---|---|---|
| Safety Standards Compliance | Non-Clinical Tests: Compliance with various ISO 7176 standards, ISO 10993-1, ISO 7176-21 for EMC. This serves as acceptance criteria indicating the device's safety. | Non-clinical tests were conducted and met all design specifications and comply with the following standards:- Biocompatibility: ISO10993-1 requirements met for all user-contacting materials.- EMC: ISO7176-21 compliant.- Performance (General Safety & Functionality): - ISO 7176-1 (Static stability) compliant. - ISO 7176-2 (Dynamic stability of electrically powered wheelchairs) compliant. - ISO 7176-3 (Effectiveness of brakes) compliant. - ISO 7176-4 (Energy consumption/range) compliant. - ISO 7176-5 (Overall dimensions, mass, maneuvering space) compliant. - ISO 7176-6 (Max speed, acceleration, deceleration) compliant. - ISO 7176-7 (Seating and wheel dimensions) compliant. - ISO 7176-8 (Static, impact, fatigue strengths) compliant. - ISO 7176-9 (Climatic tests) compliant. - ISO 7176-10 (Obstacle-climbing ability) compliant. - ISO 7176-14 (Power and control systems) compliant. - ISO 7176-16 (Resistance to ignition of postural support devices) compliant.Specific Performance Parameters (compared to predicate):- Minimum braking distance and time: 0.7 meter for 6km/h speed, <1s (S.E. to predicate's 1.1 meter for 6km/h, <1s). This shows the device meets or exceeds the predicate's performance in safety critical braking.- Max speed Forward: 6 km/h (S.E. to predicate).- Max speed Reverse: 2 km/h (S.E. to predicate's 3 km/h). Minor difference, concluded "S.E."- Maximum Occupant Mass: 120 KG (S.E. to predicate).- Maximum Incline: ≥ 15° for all directions (S.E. to predicate). |
| Functional Equivalence to Predicate | "Minor differences... do not raise any concerns in terms of safety and effectiveness." (e.g., Indication for Use, Motor Type, Batteries, Charger Type, Actuator, Brake, Wheel Lock, Operating surface & environment) | Substantial Equivalence (S.E.) demonstrated for:- Indication for use: Motor driven, indoor/outdoor transportation for disabled/elderly limited to seated position.- Motor Type: 24V DC brush differential front axle (subject) vs. rear axle (predicate) - deemed S.E.- Motor Output: 24V 180W (S.E. to predicate).- Batteries: Lithium battery (S.E. to predicate).- Range per Charge: 6 hours (S.E. to predicate).- Charger Type: Carry-on (S.E. to predicate).- Actuator: Intelligent, Regenerative and Electromagnetic brake system (S.E. to predicate).- Brake: Electromagnetic brake (S.E. to predicate).- Wheel Lock (type): Electromagnetic brake (S.E. to predicate).- Back Upholstery: Leather package (S.E. to predicate).- Operating surface & environment: Indoor and outdoor use (S.E. to predicate).Similar/Different but deemed acceptable:- Overall Dimensions: Similar (1170x550x950 mm vs 1050x550x870 mm).- Folded Dimensions: Similar (370x550x670 mm vs 480x550x790 mm).- Weight with batteries: Similar (16.7 KG vs 29 KG).- Weight without batteries: Similar (15 KG vs 24.2 KG).- Controller: Different (MM32SPIN05X vs British PG Controller PG45A) - Accepted as "Different" but not impacting S.E.- Drive Style: Different (Front-wheel drive vs Rear-wheel drive) - Accepted as "Different" but not impacting S.E.- Charger Input/Output Power: Similar (100-240VAC 50/60Hz 2A vs 100-240VAC 50/60Hz 1.2-0.5A).- Rear Wheels Size: Similar (10 inches vs 8 inches).- Front Tire Size: Similar (8 inches vs 7 inches).- Anti-tip Wheels: Different (N/A vs 2.5 inches) - Accepted as "Different" but not impacting S.E.- Curb Climbing ability: Different (40 mm vs 60 mm) - Accepted as "Different" but not impacting S.E.- Ground clearance: Different (100 mm vs 50 mm) - Accepted as "Different" but not impacting S.E.- Minimum Turning Radius: Different (1.97 m vs 1.2m) - Accepted as "Different" but not impacting S.E.- Footplates: Different (Aluminum vs ABS plastics) - Accepted as "Different" but not impacting S.E.- Tire Pressure (if pneumatic): N/A (subject) vs NA (predicate) - S.E. |
Detailed Responses to Specific Questions:
-
A table of acceptance criteria and the reported device performance:
- Please see the table above. The "acceptance criteria" for this device are demonstrated by its compliance with various ISO standards for safety and performance (the non-clinical tests) and by showing that its specifications are substantially equivalent to a legally marketed predicate device, even with some differences that are deemed not to raise new questions of safety or effectiveness.
-
Sample sizes used for the test set and the data provenance:
- N/A. This is a physical medical device (electric scooter), not an AI/software device requiring a "test set" of data in the typical sense. Performance is verified through engineering tests on the physical product and comparison to specifications and a predicate device. There is no mention of a "test set" of patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth as defined for diagnostic AI models (e.g., radiologist reads, pathology) is not relevant for this device. The "ground truth" here is established by engineering standards, physical measurements, and compliance testing performed by qualified test labs/engineers.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No multi-reader or adjudication process for a "test set" is applicable.
-
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:
- N/A. This is not an AI-assisted diagnostic device. No MRMC study was conducted or relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not an algorithm-only device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's safety and effectiveness is established by:
- Compliance with recognized international performance and safety standards (ISO 7176 series, ISO 10993-1, ISO 7176-21).
- Engineering specifications and test results of the physical device.
- Demonstrated substantial equivalence to a predicate device, meaning its performance falls within acceptable parameters compared to a device already deemed safe and effective.
- The "ground truth" for this device's safety and effectiveness is established by:
-
The sample size for the training set:
- N/A. No training set for an AI model.
-
How the ground truth for the training set was established:
- N/A. No training set for an AI model.
Conclusion from the Document (Section 9.0):
"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." This statement summarizes the "proof" that the device meets its regulatory acceptance criteria for substantial equivalence.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| Julia E. | Julia E. Slocomb -S |
|---|---|
| Slocomb -S | 2023.02.22 13:36:19-05'00' |
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
{2}------------------------------------------------
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)
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) 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 : (44)-0-203 143 5168 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: 608-217-9358 Email: cyshen@aol.com
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 |
{4}------------------------------------------------
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
{5}------------------------------------------------
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) | SubstantialEquivalence |
|---|---|---|---|
| Indication for use | It is a motor driven, indoor andoutdoor transportation vehicle withthe intended use to provide mobilityto a disabled or elderly person limitedto a seated position. | It is a motor driven, indoor andoutdoor transportation vehicle withthe intended use to provide mobilityto a disabled or elderly personlimited 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 withoutbatteries | 15 KG | 24.2 KG | Similar |
| Controller | MM32SPIN05X from Mindmotion | British PG Controller PG45A | Different |
| Drive Style (e.g., rear,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-board/Off-board/Carry- on) | Carry-on | Carry-on | S.E. |
| Charger Input /Output Power | 100-240VAC 50/60Hz 2A | 100-240VAC 50/60Hz 1.2.-0.5A | Similar |
| Actuator | Intelligent, Regenerative andElectromagnetic brake system | Intelligent, Regenerative andElectromagnetic brake system | S.E. |
Table5.1: Comparison of Intended Use, Design, and Material
{6}------------------------------------------------
| Brake | Electromagnetic brake | Electromagnetic brake | S.E. |
|---|---|---|---|
| Minimum brakingdistance and time | 0.7 meter for the speed of 6km/h<1s | 1.1 meter for the speed of 6km/h<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 (ifpneumatic) | N/A | NA | S.E. |
| Anti-tip Wheels | N/A | 2.5 inches | Different. |
| Maximum OccupantMass | 120 KG | 120 KG | S.E |
| Curb Climbing ability | 40 mm | 60 mm | Different |
| Ground clearance | 100 mm | 50 mm | Different |
| Minimum TurningRadius | 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 &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 withISO10993-1 requirements. |
| EMC | ISO7176-21: Wheelchairs - Part 21: Requirements and testmethods for electromagnetic compatibility of electrically |
{7}------------------------------------------------
| powered wheelchairs and scooters, and battery chargers | |
|---|---|
| Performance | ISO 7176-1: Wheelchairs - Part 1: Determination of staticstability |
| ISO 7176-2: Wheelchairs - Part 2:Determination of dynamicstability of electrically powered wheelchairs | |
| ISO 7176-3: Wheelchairs - Part 3: Determination ofeffectiveness of brakes | |
| ISO 7176-4: Wheelchairs - Part 4: Energy consumption ofelectric wheelchairs and scooters for determination oftheoretical distance range | |
| ISO 7176-5: Wheelchairs - Part 5: Determination of overalldimensions, mass and manoeuvring space | |
| ISO 7176-6: Wheelchairs - Part 6: Determination of maximumspeed, acceleration and deceleration of electric wheelchairs | |
| ISO 7176-7: Wheelchairs - Part 7: Measurement of seating andwheel dimensions | |
| ISO 7176-8: Wheelchairs - Part 8: Requirements and testmethods for static, impact and fatigue strengths | |
| ISO 7176-9: Wheelchairs - Part 9: Climatic tests for electricwheelchairs | |
| ISO 7176-10: Wheelchairs - Part 10: Determination ofobstacle-climbing ability of electrically powered wheelchairs | |
| ISO 7176-14: Wheelchairs - Part 14: Power and controlsystems for electrically powered wheelchairs and scooters -Requirements and test methods | |
| ISO 7176-16: Wheelchairs - Part 16: Resistance to ignition ofpostural 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.
§ 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).