(93 days)
Not Found
No
The description focuses on mechanical and electrical components and control mechanisms, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a mobility aid for transportation, not a device used for treating or curing a medical condition.
No
The device is described as an indoor/outdoor electric scooter intended to provide mobility, not to diagnose medical conditions or diseases.
No
The device description clearly outlines a physical scooter with a metal frame, wheels, seat, motor, brakes, and batteries, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The eFOLDI Scooter, Lite is a mobility device. Its function is to provide transportation and aid mobility for individuals with limitations. It does not analyze any biological samples or provide diagnostic information.
- Intended Use: The intended use clearly states it's for "indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position." This is a functional aid, not a diagnostic tool.
- Device Description: The description details the physical components and operation of a scooter, not equipment for analyzing biological samples.
- Lack of Relevant Information: The document lacks any mention of biological samples, assays, reagents, or any other elements associated with in vitro diagnostics.
Therefore, based on the provided information, the eFOLDI Scooter, Lite is a mobility device and not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
INI
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.
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
Not Found
Intended User / Care Setting
disabled or elderly person
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. The test results demonstrated that the proposed device complies with the following standards:
Biocompatibility: All user directly contacting materials are compliance with ISO10993-1 requirements.
EMC: ISO7176-21: Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
Performance:
ISO 7176-1: Wheelchairs - Part 1: Determination of static stability
ISO 7176-2: Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
ISO 7176-3: Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4: Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5: Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
ISO 7176-6: Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
ISO 7176-7: Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8: Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-9: Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ISO 7176-10: Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-14: Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
ISO 7176-16: Wheelchairs - Part 16: Resistance to ignition of postural support devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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)
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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) | Substantial
Equivalence |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Indication 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 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
batteries | 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 and
Electromagnetic brake system | Intelligent, Regenerative and
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 | |||
| distance and time | 0.7 meter for the speed of 6km/h |