Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and electrical components, standard controls, and Bluetooth communication, with no mention of AI or ML algorithms for control, navigation, or other functions.

Therapeutic

No
The device is a mobility aid for transportation and does not address a disease, injury, or disability by restoring, modifying, or establishing body functions or structures.

Diagnostic

No

The device is described as a transportation vehicle and mobility aid for disabled or elderly persons, not a tool for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, motor-driven vehicle with numerous hardware components (frame, wheels, motors, battery, etc.). While it has Bluetooth communication and a smartphone app, it is fundamentally a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the WHILL Model R is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is clearly stated as providing mobility to a disabled or elderly person. This is a physical function, not a diagnostic test performed on biological samples.
Device Description: The description details a mobility scooter with mechanical and electrical components for transportation. There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological specimens
- Diagnostic purposes (identifying diseases, conditions, etc.)
- Measurement of biomarkers or analytes

The testing performed (ISO 7176, ISO 10993, electrical safety, software validation, etc.) is consistent with a medical device for mobility, not an IVD.

Therefore, the WHILL Model R is a mobility aid, which is a type of medical device, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Model R 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

INI

Device Description

WHILL Model R is an indoor/outdoor electric scooter that is intended as a mobility aid for elderly persons or persons with reduced mobility. Providing Bluetooth-based radio communications functionalities.

Model R is available in two variants, the 3-wheel model and the 4-wheel model. The 3-wheel scooter has a base with metal alloy frame, one front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, 2 electric motors, 2 electromagnetic brakes, a rechargeable lithium-ion battery with an off-board charger.

The 4-wheel scooter has a base with metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, 2 electric motors, 2 electromagnetic brakes, a rechargeable lithium-ion battery with an off-board charger.

The only difference between 3-wheel model and 4-wheel model is front drive-base component. The 3-wheel model has a single front tire, while the 4-wheel model has two front tires. Besides this difference in mechanical design, other parts of the device are identical across the two models. Customers can choose a model depending on their preferences and use case.

Model R has a removable lithium-ion battery, a swivel 17-inch-wide seat with two armrests and front and rear LED lights. The battery may be charged either when installed within the device or when removed.

Some components are adjustable to provide user with a comfortable riding position. The inner width and the height of the armrests are adjustable in 3 positions. The seat position from the tiller is adjustable in 4 positions. The seat height is adjustable in 2 positions and the tiller angle is also adjustable. A lap belt is equipped for posture support and for safety.

As with all conventional powered scooters, to drive the Model R, the user sits in the seat and grips the tiller handle around the controller unit which is positioned in front of the user. While gripping the tiller handle, the user uses their fingers to pull the right side of the throttle control lever gently to drive the device forward. The degree at which the throttle control lever is pulled is positively proportional to the speed of the device. When the throttle control lever returns to its original position after the user releases it, the device decelerates and comes to a stop. When the user uses their fingers to pull on the left side of the lever, the device drives backwards. To move to the left, the user turns the tiller handle to the left, and, to the right, the user turns the tiller handle to the right.

Model R has Bluetooth-based radio communications capabilities. The user can power on Model R with a physical key, a Bluetooth smart key fob or with a dedicated smartphone app. The user can select speed profiles, turn off and on the front LED light and sound the audible warning device by operating the controller unit.

User can disassemble Model R into four components, i.e. drive base, main body, seat base assembly and battery, without the use of tools when loading into a car for transportation.

The device supports a maximum weight of 147 kg (325 lbs.), including the weight of the occupant and any carried items. The 3-wheel model has a theoretical continuous driving range of 18.7 km (11.6 miles) while the 4-wheel model has a theoretical continuous driving range of 17.2 km (10.7 miles).

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 limited to a seated position.

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 performance testing: The subject device, primary predicate, reference device were tested to the ISO 7176 standards. These standards are listed in the FDA document entitled "Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs and Motorized Three-Wheeled Vehicles."
Key Results: All tests showed substantial equivalence (S.E.).

Biocompatibility Testing: Biocompatibility assessment of patient-contacting components in the subject device was performed in conformance with ISO 10993-1, "biological evaluation of medical devices - part 1: evaluation and testing within a risk management process" as recognized by FDA.
Key Results: All tests showed substantial equivalence (S.E.).

Electrical Safety and Electromagnetic Compatibility testing: Electrical Safety and Electromagnetic Compatibility testing was performed on a sample of battery and battery chargers in the subject device and test samples were found to conform with the following test standards.
Key Results: All tests showed equivalence.

Software Verification and Validation Testing: Software Verification and Validation Testing was conducted per the requirements of ANSI AAMI IEC 62304:2006/A1:2015.

FCC Radio Frequency Testing: The Radiofrequency wireless technology was tested to FCC requirements and found to comply with 47 CFR 15.249.

Wireless Co-existence Testing: The performance of WHILL Model F was evaluated in an environment with other WHILL Model F devices and with different types of 2.4 GHz wireless device met all specified requirements listed in ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence.

Usability Testing: Usability was validated following IEC 62366-1:2015.

Animal Study: Animal performance testing was not required to demonstrate the safety and effectiveness of the device.

Human Clinical Performance Testing: Clinical testing was not required to demonstrate the safety and effectiveness of the device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K222495

Reference Device(s)

K221438

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

January 6, 2025

Whill, Inc. % Bhoomika Joyappa Senior Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Road Cuttingsville, Vermont 05738

Re: K242760

Trade/Device Name: WHILL Model R Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: November 27, 2024 Received: December 2, 2024

Dear Bhoomika Joyappa:

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.

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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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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assistance/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,

Tushar Bansal -S

for 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

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Indications for Use

Submission Number (if known)

K242760

Device Name

WHILL Model R

Indications for Use (Describe)

The Model R 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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510(k) SUMMARY

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

l. SUBMITTER Whill, Inc. 2-1-11 Higashi-Shinagawa; Harbor Premium Building 2F Shinagawa-ku, Tokyo 140-0002 Japan Phone: +819025672984 Contact Person: Tsuyoshi Iriyama Date Prepared: August 21, 2024

II. SUBJECT DEVICE

Trade Name:	WHILL Model R
510(k):	K242760
Classification Name:	Motorized three-wheeled vehicle
Regulation:	21 CFR § 890.3800
Regulatory Class:	Class II
Product Classification Code:	INI

III. PREDICATE DEVICE

Manufacturer:	Zhejiang Innuovo Rehabilitation Devices Co., Ltd
Trade Name:	Mobility Scooter, Model: W3331F
510(k):	K222495
Classification Name:	Motorized three-wheeled vehicle
Regulation:	21 CFR § 890.3800
Regulatory Class:	Class II
Classification Product Code:	INI

IV. REFERENCE DEVICE

Manufacturer:	Whill, Inc.
Trade Name:	WHILL Model F
510(k):	K221438
Classification Name:	Powered wheelchair
Regulation:	21 CFR § 890.3860
Regulatory Class:	Class II
Classification Product Code:	ITI

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V. DEVICE DESCRIPTION