Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard powered wheelchair with Bluetooth remote control capabilities, but there is no mention of AI or ML in the device description, performance studies, or any other section.

Therapeutic

No.
The device is a powered wheelchair intended for mobility, not to treat or cure a medical condition.

Diagnostic

No
This device is a powered wheelchair designed for mobility, not for diagnosing medical conditions. Its intended use is to provide outdoor and indoor mobility to individuals limited to a seated position.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as motors, brakes, battery, and a physical control system (joystick). While it includes a smartphone app for remote control and settings, the core functionality and operation rely on the physical wheelchair hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to provide mobility to individuals with limited mobility. This is a physical function, not a diagnostic test performed on biological samples.
Device Description: The description details a powered wheelchair with components related to movement, control, and power. There is no mention of analyzing biological samples or providing diagnostic information.
Performance Studies: The performance studies focus on safety, electrical compatibility, software validation, and usability, all related to the function of a mobility device. There are no studies related to diagnostic accuracy or analysis of biological markers.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of blood, urine, tissue, or other biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on biological analysis.

Therefore, the WHILL Model C2 powered wheelchair is a medical device, but it falls under the category of a mobility aid, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of the WHILL Model C2 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Product codes (comma separated list FDA assigned to the subject device)

ITI

Device Description

The subject device is an update to the existing previously cleared WHILL Model M (K153543). The WHILL Model C2 is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. It consists of four parts: seat system, braking system, and drive system. It consists of two motors drive systems, an electromagnetic braking system, an electric motor controller, and a lithium-ion battery with an off-board battery charger. The wheelchair is powered by a 25.3V DC 10.6A rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger.

The control system, including the directional controller (joystick), is equipped on the control pad that attaches to the armrest. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.

As with all commercially available powered wheelchairs, the user sits in the wheelchair seat and uses the control system such as the control pad positioned on either of the two arms to turn the chair on, control the speed, and direct the movement. Adjustments can be made to the seating to fit the user's body. Like the predicate device WHILL Model M, the two side-arms can be rotated out of the way to make it easier for the user to get into and out of the device.

Model C2 also contains Bluetooth-based RF wireless technology. The wireless technology is identical to the legally marketed reference device 2, e-motion-M25 (K192618). The device can be controlled by the directional controller or remote control by a smartphone app via Bluetooth Low Energy (BLE) wireless communication interface. The smartphone app is used to drive the chair remotely. (Note: For safety, Joystick control is priority over the remote control by design.) The smartphone app can also view the battery's status, adjust the speed and acceleration setting and lock the unattended device. The user can lock and unlock the device remotely via the BLE interface using the smartphone app or using a smart key fob.

The device supports a maximum weight of 136Kg (300lbs.), including the weight of the occupant and any carried items. It has a maximum driving range of 11miles (18km) with a maximum speed limit of up to 5mph (8km/h).

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

Not Found

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 1, and the reference device 2 were tested to the ISO 7176 standard, while the primary predicate device was tested to the RESNA WC-1 and WC-2 standard. Both standards are listed as acceptable per the FDA document entitled "Guidance Document for the Preparation of Premarket Notification [510k]] Applications for Mechanical and Powered Wheelchairs and Motorized Three-Wheeled Vehicles." Safety and performance data provided in support of substantial equivalence determination.

Biocompatibility Testing: Biocompatibility assessment of patient-contacting components in the subject device was performed with ISO 10993-1, "biological evaluation of medical devices - part 1: evaluation and testing within a risk management process" as recognized by FDA. The evaluated endpoints were Non-Cytotoxic, Non-Sensitizing, and Non-irritating, all of which passed.

Electrical Safety and Electromagnetic Compatibility testing: Performed on a sample of battery chargers in the subject device and found to conform with various IEC and EN standards including IEC 60601-1-2 and ETSI EN 301 489-1.

Software Verification and Validation Testing: Conducted per the requirements of ANSI AAMI IEC 62304:2006/A1:2015. The Level of Concern for the software is moderate.

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 C2 was evaluated in an environment with other WHILL Model C2 devices and with different types of 2.4 GHz wireless devices. The 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K153543

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K182576, K192618

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).

Summary

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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

November 9, 2021

Whill, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K213383

Trade/Device Name: WHILL Model C2 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: October 12, 2021 Received: October 13, 2021

Dear Prithul Bom:

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.

1

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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

2

Indications for Use

510(k) Number (if known) K213383

Device Name WHILL Model C2

Indications for Use (Describe)

The intended use of the WHILL Model C2 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

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) SUMMARY: K213383

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

I.	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: July 15, 2021
II.	DEVICE

Name of Device:	WHILL Model C2
Classification Name:	Physical Medicine
Regulation:	21 CFR § 890.3860
Regulatory Class:	Class II
Product Classification Code:	ITI

PREDICATE DEVICE III.

Primary Predicate Device

Manufacturer: Whill, Inc. ●
. Trade Name: WHILL Model M
510(k): K153543
Classification Name: Physical Medicine
. Regulation: 21 CFR § 890.3860
. Regulatory Class: Class II
Product Classification Code: ITI ●

IV. REFERENCE DEVICES

Reference Device 1

Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd
Trade Name: Solax Powered Wheelchair ●
510(k): K182576
. Classification Name: Physical Medicine
Regulation: 21 CFR § 890.3860 ●
Regulatory Class: Class II
- . Product Classification Code: ITI

Reference Device 2

Manufacturer: Alber GmbH
. Trade Name: e-motion M25
510(k): K192618
Classification Name: Physical Medicine
. Regulation: 21 CFR § 890.3860
. Regulatory Class: Class II
Product Classification Code: ITI

V. DEVICE DESCRIPTION

4

The subject device is an update to the existing previously cleared WHILL Model M (K153543). The WHILL Model C2 is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair. It consists of four parts: seat system, braking system, and drive system. It consists of two motors drive systems, an electromagnetic braking system, an electric motor controller, and a lithium-ion battery with an off-board battery charger. The wheelchair is powered by a 25.3V DC 10.6A rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger.

The control system, including the directional controller (joystick), is equipped on the control pad that attaches to the armrest. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.

As with all commercially available powered wheelchairs, the user sits in the wheelchair seat and uses the control system such as the control pad positioned on either of the two arms to turn the chair on, control the speed, and direct the movement. Adjustments can be made to the seating to fit the user's body. Like the predicate device WHILL Model M, the two side-arms can be rotated out of the way to make it easier for the user to get into and out of the device.

Model C2 also contains Bluetooth-based RF wireless technology. The wireless technology is identical to the legally marketed reference device 2, e-motion-M25 (K192618). The device can be controlled by the directional controller or remote control by a smartphone app via Bluetooth Low Energy (BLE) wireless communication interface. The smartphone app is used to drive the chair remotely. (Note: For safety, Joystick control is priority over the remote control by design.) The smartphone app can also view the battery's status, adjust the speed and acceleration setting and lock the unattended device. The user can lock and unlock the device remotely via the BLE interface using the smartphone app or using a smart key fob.

The device supports a maximum weight of 136Kg (300lbs.), including the weight of the occupant and any carried items. It has a maximum driving range of 11miles (18km) with a maximum speed limit of up to 5mph (8km/h).

VI. INDICATIONS FOR USE

The intended use of the WHILL Model C2 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PRIMARY PREDICATE VII. DEVICE

The indications for use, design, and function of the subject device are identical to the primary predicate device WHILL Model M (K153543). The following characteristics were compared between the subject device and the predicate devices to demonstrate substantial equivalence:

Indications for Use: WHILL Model C2 has the same indications of use, principles of operation, O and similar technical characteristics as the previously cleared primary predicate device, WHILL Model M (K153543). Both are indicated for indoor and outdoor mobility to persons limited to a seated position capable of operating a powered wheelchair.

5

Materials: The subject device has more surface contacting components than the primary O predicate device, and the subject device's surface-contacting parts are tested to ISO 10993 standard.
Design: The subject device uses the same technology as the primary predicate device. The O key differences are that the subject device is a rear-wheel drive, uses Brushless DC motors over brushed DC motors to achieve lightweight and portability, uses WHILL Motor controller over R-Net power module, and the device controls are on one arm instead of two. These features have been safety and performance-tested to ISO 7176 standard. The testing demonstrates that the differences do not raise new questions of safety or effectiveness.
Energy Source: The subject device and the primary predicate are both powered by batteries. O The key difference is that the subject device uses a Lithium-ion battery over lead-acid batteries for compatibility with the brushless DC motors. The Lithium-ion battery used in the subject device has been safety tested to IEC 62133-2 standard.
O Performance Testing: Both the predicate and subject devices were subjected to the same biocompatibility and performance tests listed below in Section-X

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE REFERENCE DEVICE 1 VIII.

The subject device is for Over-the-Counter use. Hence Solax Powered Wheelchair- S7102 (K182576) is chosen as the reference device 1 to account for the OTC indication.

Indications for Use: WHILL Model C2 has similar indications of use, principles of operation, o and similar technical characteristics as the reference device 1, Solax Powered Wheelchair (K182576). Although there is a minor difference in the indications of use, the primary indication of both the subject device and the reference device 1 is to assist with mobility to users limited to a seated position who can operate and control the powered wheelchair.
Materials: The subject device has more surface contacting components tested to ISO 10993 O standard. There is no mention of the surface contacting components and biocompatibility test for reference device 1 in the 510(k) summary
Energy Source: The subject device and the reference device 1 are both powered by a Lithium- O ion battery. The Lithium-ion battery used in the subject device has been safety tested to /EC 62133-2 standard.
Performance Testing: Both the reference device 1 and subject devices were subjected to the O same performance tests listed below in Section-X

IX. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE REFERENCE DEVICE 2

The subject device includes an additional feature of Radio Frequency wireless technology. To account for the additional feature, e-motion-M25(K192618) is chosen as the reference device 2. The RF wireless technology and standards are identical to the reference device 2. The following characteristics and standards were compared between the subject device and the reference device 2:

Wireless functionality. The subject device and the reference device 2 have similar wireless o functionality of controlling the device with a smartphone app (iOS, Android) via Bluetooth Low Energy.
Wireless RF frequency range: Both the primary and reference device 2 have an identical O

6

Wireless RF frequency range.

Wireless operating range: Both the primary and reference device 2 have an identical operating range.
Wireless testing: Both the reference device 2 and subject devices were subjected to the same FCC Radio Frequency Testing and wireless co-existence testing listed below in Section-X

X. SAFETY AND PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination. (Table 1 Table 2 Table 3)

Sterilization & Shelf-life Testing

The device is provided non-sterile and is used non-sterile. There are no parts that can expire, and thus, there is no shelf life.

Non-clinical performance testing:

The subject device, primary predicate, reference device 1, and the reference device 2 were tested to the ISO 7176 standard, while the primary predicate device was tested to the RESNA WC-1 and WC-2 standard. Both standards are listed as acceptable per the FDA document entitled "Guidance Document for the Preparation of Premarket Notification [510k]] Applications for Mechanical and Powered Wheelchairs and Motorized Three-Wheeled Vehicles."

7

| Subject Device
WHILL Model C2 | Primary Predicate Device
WHILL Model M (K153543) | Reference Device 1
Solax Powered Wheelchair
(K182576) | Reference Device 2
e-motion M25 (K192618) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 7176-1 Third edition
2014-10-01 Wheelchairs -
Part 1: Determination of
static stability | American National Standard for Wheelchairs -
RESNA Volume 1: Requirements and Test Methods
for Wheelchairs (Including Scooters) Section 1
Determination of Static Stability | ISO 7176-1: 2014, Wheelchairs -
Part 1: Determination of static
stability | ISO 7176-1 Wheelchairs - Part 1:
Determination of static stability |
| ISO 7176-2 Third edition
2017-10 Wheelchairs - Part
2:Determination of dynamic
stability of electrically
powered wheelchairs | American National Standard for Wheelchairs -
Volume 2: Additional Requirements for
Wheelchairs (Including Scooters) With Electrical
Systems Section 2: Determination of Dynamic
Stability of Electrically Powered Wheelchairs | ISO 7176-2 Wheelchairs - Part 2:
Determination of dynamic stability
of electric wheelchairs | ISO 7176-2 Wheelchairs – Part 2:
Determination of dynamic stability of
electric wheelchairs |
| ISO 7176-3 Third edition
2012-12-15 Wheelchairs -
Part 3: Determination of
effectiveness of brakes | American National Standard for Wheelchairs -
Volume 2: Additional Requirements for
Wheelchairs (Including Scooters) With Electrical
Systems Section 3: Determination of Effectiveness
of Brakes | ISO 7176-3: 2012, Wheelchairs - Part
3: Determination of effectiveness of
brakes | ISO 7176-3 Wheelchairs - Part 3:
Determination of efficiency of brakes |
| ISO 7176-4 Third edition
2008-10-01Wheelchairs -
Part 4: Energy consumption
of electric wheelchairs and
scooters for determination
of theoretical distance
range | American National Standard for Wheelchairs -
Volume 2: Additional Requirements for
Wheelchairs (Including Scooters) With Electrical
Systems Section 4: Energy Consumption of
Electrically Powered Wheelchairs and Scooters for
Determination of Theoretical Distance | 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 7176-4 Wheelchairs – Part 4: Energy
consumption of electric wheelchairs and
scooters for determination of theoretical
distance range |
| ISO 7176-5 Second edition
2008-06-01Wheelchairs -
Part 5: Determination of
overall dimensions, mass
and maneuvering space | American National Standard for Wheelchairs -
Volume 1: Requirements and Test Methods for
Wheelchairs (Including Scooters) Section 5:
Determination of Dimensions, Mass and
Maneuvering Space | ISO 7176-5, Second edition 2008-06-
01, Wheelchairs - Part 5:
Determination of overall dimensions,
mass and maneuvering space | ISO 7176-5 Wheelchairs – Part 5:
Determination of dimensions, mass, and
maneuvering space |
| Subject Device
WHILL Model C2 | Primary Predicate Device
WHILL Model M (K153543) | Reference Device 1
Solax Powered Wheelchair
(K182576) | Reference Device 2
e-motion M25 (K192618) |
| ISO 7176-6 Third edition
2018-06 Wheelchairs - Part
6: Determination of
maximum speed,
acceleration and
deceleration of electric
wheelchairs | American National Standard for Wheelchairs -
Volume 2: Additional Requirements for
Wheelchairs (Including Scooters) With Electrical
Systems Section 6: Determination of Maximum
Speed, Acceleration and Deceleration of
Electrically Powered Wheelchairs | ISO 7176-6: 2001, Wheelchairs - Part
6: Determination of maximum
speed, acceleration and deceleration
of Powered Wheelchairs | ISO 7176-6 Wheelchairs – Part 6:
Determination of maximum speed,
acceleration, and deceleration of electric
wheelchairs |
| ISO 7176-8 Second edition
2014-12-15 Wheelchairs -
Part 8: Requirements and
test methods for static,
impact and fatigue
strengths | American National Standard for Wheelchairs -
Volume 1: Requirements and Test Methods for
Wheelchairs (Including Scooters) Section 8:
Requirements and Test Methods for Static, Impact
And Fatigue Strengths | ISO 7176-8:2014, Wheelchairs - Part
8: Requirements and test methods
for static, impact and fatigue
strengths | ISO 7176-8 Wheelchairs – Part 8:
Requirements and test methods for static,
impact, and fatigue strengths |
| ISO 7176-9 Third edition
2009-11-15Wheelchairs -
Part 9: Climatic tests for
electric wheelchairs | American National Standard for Wheelchairs -
Volume 1: Requirements and Test Methods for
Wheelchairs (Including Scooters) Section 9:
Climatic Tests for Electrically Powered Wheelchairs | ISO 7176-9:2009, Wheelchairs - Part
9: Climatic tests for Powered
Wheelchairs | ISO 7176-9 Wheelchairs - Part 9: Climatic
tests for electric wheelchairs |
| ISO 7176-10 Second edition
2008-11 01Wheelchairs -
Part 10: Determination of
obstacle-climbing ability of
electrically powered
wheelchairs | American National Standard for Wheelchairs -
Volume 2: Additional Requirements for
Wheelchairs (Including Scooters) With Electrical
Systems Section 10: Determination of Obstacle-
Climbing Ability of Electrically Powered
Wheelchairs | ISO 7176-10:2008, Wheelchairs -
Part 10: Determination of obstacle-
climbing ability of electrically
powered wheelchairs | ISO 7176-10 Wheelchairs – Part 10:
Determination of obstacle-climbing ability
of electrically powered wheelchairs |
| ISO 7176-11 Second edition
2012-12-01Wheelchairs -
Part 11: Test dummies | American National Standard for Wheelchairs -
Volume 1: Requirements and Test Methods for
Wheelchairs (Including Scooters) Section 11: Test
Dummies | ISO 7176-11, Second edition 2012-
12-01, Wheelchairs - Part 11: Test
dummies | ISO 7176-11 Wheelchairs - Part 11: Test
Dummies |
| Subject Device
WHILL Model C2 | Primary Predicate Device
WHILL Model M (K153543) | Reference Device 1
Solax Powered Wheelchair
(K182576) | Reference Device 2
e-motion M25 (K192618) |
| ISO 7176-13: 1989
Wheelchairs - Part 13:
Determination of Coefficient
of Friction of Test Surfaces | American National Standard for Wheelchairs -
Volume 1: Requirements and Test Methods for
Wheelchairs (Including Scooters) Section 13:
Determination of Coefficient of Friction of Test
Surfaces | ISO 7176-13, First edition 1989-08-
01, Wheelchairs - Part 13:
Determination of coefficient of
friction of test surfaces | ISO 7176-13: 1989 Wheelchairs - Part 13:
Determination of Coefficient of Friction of
Test Surfaces |
| ISO 7176-14 Second edition
2008-02-15 Wheelchairs -
Part 14: Power and control
systems for electrically
powered wheelchairs and
scooters - Requirements
and test methods | American National Standard for Wheelchairs -
Volume 2: Additional Requirements for
Wheelchairs (Including Scooters) With Electrical
Systems Section 14: Power and Control Systems
for Electrically Powered Wheelchairs -
Requirements and Test Methods | ISO 7176-14:2008, Wheelchairs -
Part 14: Power and control systems
for electrically powered wheelchairs
and scooters - Requirements and
test methods | ISO 7176-14 Wheelchairs - Part 14: Power
and control systems for electrically
powered wheelchairs and scooters.
Requirements and test methods |
| ISO 7176-15 First edition
1996-11-15 Wheelchairs -
Part 15: Requirements for
information disclosure,
documentation and labeling | American National Standard for Wheelchairs -
Volume 1: Requirements and Test Methods for
Wheelchairs (Including Scooters) Section 15:
Requirements for information disclosure,
documentation, and labeling | ISO 7176-15:1996, Wheelchairs -
Part 15: Requirements for
information disclosure,
documentation and labeling | ISO 7176-15 Wheelchairs – Part 15:
Requirements for information disclosure,
documentation, and labeling |
| Subject Device
WHILL Model C2 | Primary Predicate Device
WHILL Model M (K153543) | Reference Device 1
Solax Powered Wheelchair
(K182576) | Reference Device 2
e-motion M25 (K192618) |
| ISO 7176-16 Wheelchairs –
Part 16: Resistance to
ignition of postural support
devices- ISO 8191-2:1988
Furniture — Assessment
of ignitability of
upholstered furniture —
Part 2: Ignition source:
match-flame equivalent | Cushions used are purchased components that are
FDA-listed and compliant with ISO 8191-1 and ISO
8191-2, covers are compliant with ISO 7176-16 | ISO 7176-16, Second edition 2012-
12-01, Wheelchairs - Part 16:
Resistance to ignition of postural
support devices | ISO 7176-16 Wheelchairs – Part 16:
Resistance to ignition of postural support
devices |
| ISO 7176-21 Second edition
2009-04-01Wheelchairs -
Part 21: Requirements and
test methods for
electromagnetic
compatibility of electrically
powered wheelchairs and
scooters, and battery
chargers | American National Standard for Wheelchairs -
Volume 2, Additional Requirements for
Wheelchairs (Including Scooters) With Electrical
Systems Section 21: Requirements and Test
Methods for Electromagnetic Compatibility of
Electrically Powered Wheelchairs and Motorized
Scooters | ISO 7176-21 Second edition 2009-
04-01 Wheelchairs - Part 21:
Requirements and test methods for
electromagnetic compatibility of
electrically powered wheelchairs and
scooters, and battery chargers | -ISO 7176-21 Wheelchairs – Part 21:
Requirements and test methods for
electromagnetic compatibility |
| ISO 7176-22 Second edition
2014-09-01 Wheelchairs -
Part 22: Set-up procedure | ANSI RESNA WC-1:2019 Section 22
American National Standard for Wheelchairs -
Volume 1: Requirements and Test Methods for
Wheels chairs (including Scooters) Section 22: Set-
up Procedures | ISO 7176-22 Second edition 2014-
09-01 Wheelchairs - Part 22: Set-up
procedures | Not Mentioned |
| UN 38.3 Recommendations
of the TRANSPORT OF
DANGEROUS GOODS,
Manual of Test and Criteria,
Part III, Lithium metal and
lithium-ion batteries | NA | NA | UN 38.3 Recommendations of the
TRANSPORT OF DANGEROUS GOODS,
Manual of Test and Criteria, Part III, Lithium
metal and lithium-ion batteries |

Table 1 Comparison of Non-Clinical Testing WHILL Model C2 with predicate device and reference devices.

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10

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Biocompatibility Testing

Biocompatibility assessment of patient-contacting components in the subject device was performance with iso 10993-1, "biological evaluation of nedical devices - part 1: evaluation and testing within a risk management process" as recognized by FDA. The following endpoints were evaluated:

Table 2 Biocompatibility Testing

Test Standard	Acceptance criteria	Result
ISO 10993-5:2009, Biological Evaluation of
Medical Devices - Part 5: Tests For In Vitro
Cytotoxicity	Non- Cytotoxic	Pass
ISO 10993-10:2010 Biological Evaluation of
Medical Devices - Part 10: Tests for Irritation and
Skin Sensitization	Non-Sensitizing	Pass
ISO 10993-10:2010 Biological Evaluation of
Medical Devices - Part 10: Tests for Irritation and
Skin Sensitization	Non-irritating	Pass

Electrical Safety and Electromagnetic Compatibility testing

Electrical Safety and Electromagnetic Compatibility testing was performed on a sample of battery chargers in the subject device and found to conform with the following test standards.

Test Standard	Test description
IEC 60601-1-2 Edition 4.0 2014-02	Medical Electrical Equipment - Part 1-2: General Requirements for Basic
Safety and Essential Performance - Collateral Standard: Electromagnetic
Disturbances - Requirements and Tests
IEC/EN 61000-3-2:2014	Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic
current emissions (equipment input current ≤ 16 A per phase)
IEC/EN 61000-3-3:2013	Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage
changes, voltage fluctuations and flicker in public low-voltage supply
systems, for equipment with rated current ≤16 A per phase and not subject
to conditional connection
IEC/EN61000-4-2 Edition 2.0 2008-12,	Electromagnetic compatibility (EMC)- Part 4-2: Testing and measurement
techniques - Electrostatic discharge immunity test
IEC/EN61000-4-3 Edition 3.2 2010-04,	Electromagnetic compatibility (EMC)- Part 4-3: Testing and measurement
techniques - Radiated, radiofrequency, electromagnetic field immunity test
IEC/EN61000-4-4 Edition 3.0 2012-04,	Electromagnetic compatibility (EMC) Part 4-4: Testing and measurement
techniques - Electrical fast transient/burst immunity test (EFT)
IEC/EN61000-4-5 Edition 3.1 2017-08,	Electromagnetic compatibility (EMC) Part 4-5: Testing and measurement
techniques - Surge immunity test
IEC/EN61000-4-6 Edition 4.0 2013-10,	Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement
techniques - Immunity to conducted disturbances, induced by radio-
frequency fields
IEC/EN61000-4-8 Edition 2.0 2009-09,	Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement
techniques – Power frequency magnetic field immunity test
IEC/EN61000-4-11 Edition 2.1 2017-05,	Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement
techniques - Voltage dips, short interruptions and voltage variations
immunity tests
EN 61326-2-2:2013	Electrical equipment for measurement, control and laboratory use. EMC
requirements. Particular requirements. Test configurations, operational
conditions and performance criteria for portable test, measuring and
monitoring equipment used in low-voltage distribution systems
EN 61326-1:2013	EMC Emissions/Immunity Requirement Changes for Laboratory Equipment
ETSI EN 301 489-1 V2.2.3 (2019-11)	Electromagnetic Compatibility (EMC) standard for radio equipment and
services; Part 1: Common technical requirements; Harmonized Standard for
Electromagnetic Compatibility
ETSI EN 300 328 V2.2.2 (2019-07)	Wideband transmission systems; Data transmission equipment operating in
the 2,4 GHz ISM band and using wide band modulation techniques
FCC 47 CFR 15 Subpart B	Unintentional Radiators
IEC 62368-1:2018	Hazard-based electrical safety standard for IT equipment and Audio-Visual
products
IEC 62133-2 Edition1.0 2017-02	Secondary cells and batteries containing alkaline or other non-acid
electrolytes - Safety requirements for portable sealed secondary cells, and
batteries made from them, for use in portable applications - Part 2: Lithium
systems
IEC 60335-2-29:2016	Safety of household and similar electrical appliances Part 2-29: Requirements
for battery chargers

Table 3 EMC and Electrical Safety Testing

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Software Verification and Validation Testing

Software Verification and Validation Testing was conducted per the requirements of ANSI AAMI IEC 62304:2006/A1:2015. Level of Concern: The Level of Concern for the subject device software is moderate. This determination is based on answering the questions in the FDA Guidance Document "FDA Guidance for the Content of Premarket Submissions for Software in Medical Devices.

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 C2 was evaluated in an environment with other WHILL Model C2 devices and with different types of 2.4 GHz wireless devices. The 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.

Mechanical and acoustic Testing

Not Applicable.

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

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XI. Comparison with Primary Predicate Device and Reference Device 1

| Device | Subject Device
WHILL Model C2 | Primary Predicate Device
WHILL Model M (K153543) | Reference Device 1
Solax Powered Wheelchair, model: S7102
(K182576) | Remark |
|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Whill, Inc. | Whill, Inc. | Dongguan Prestige Sporting Goods Co., Ltd | Same |
| 510K Number | Unknown | K153543 | K182576 | - |
| Common or Usual
Name | Powered Wheelchair | Powered Wheelchair | Powered Wheelchair | Same |
| Product Code | ITI | ITI | ITI | Same |
| Product Classification | Class II | Class II | Class II | Same |
| Classification Name | Powered Wheelchair | Powered Wheelchair | Powered Wheelchair | Same |
| Regulation Number | 21 CFR 890.3860 | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| INDICATIONS FOR USE | | | | |
| Indications for Use | The intended use of the Model C2 powered
wheelchair is to provide outdoor and indoor
mobility to persons limited to a seated position
that are capable of operating a powered
wheelchair. | The intended use of the Model M
powered wheelchair is to provide
outdoor and indoor mobility to persons
limited to a seated position that are
capable of operating a powered
wheelchair. | The intended use of Solax Powered
wheelchair is to provide mobility to adults,
limited to a seated position that have
capability to operate a few simple controls
and the ability to control a powered
wheelchair. | -Same as the primary
predicate
-Similar to Reference
Device 1. The primary
indication of the subject
and the Reference
Device 1 is to assist
users with mobility |
| Type of Use | Over the Counter (OTC Only) | Prescription (RX Only) | Over the Counter (OTC Only) | Rationale in Note 11 |
| PHYSICAL CHARACTERISTICS COMPARISON | | | | |
| | Image: WHILL Model C2 | Image: WHILL Model M | Not available | |
| Device Construction | Solid aluminum frame | Welded nut and steel | Aluminum frame | SE-Note 1 to the
primary predicate
device
-Same as the Reference
Device 1 |
| Device Length | 38.8" | 37"- 42" (depending on foot
plate setting) | 27.1654" (610 mm) | SE-Note 1 |
| Device Width | 21.8" | 23.6" | 23.6" (600 mm) | SE-Note 1 |
| Device Height | 29.3 — 37.2" | Approximately 27.5" (Varilite Icon Back
System Low on lowest seat height) to
36.8" (Varilite Icon Back System Tall on
highest seat height) | 35.8" (910mm) | SE-Note 1 |
| Number of wheels | 4 | 4 | 4 | same |
| Front Wheel
Diameter | 10.11" | 9.8" | 6" | SE-Note 2 |
| Rear Wheel Diameter | 10.43" | 12.5" | 9" | SE-Note 2 |
| Ground Clearance | 3" | 3.5" | Not available | Similar. The minor
difference does not
affect the safety and
effectiveness of the
device |
| Battery pack | 1 rechargeable lithium-ion battery
Ratings: 25.3 V 10.5Ah | 1 set of two 12V rechargeable lead acid
batteries connected in series
Ratings: 12V DC 50 Ah (per battery) | rechargeable lithium-ion battery
Ratings: 25.9V30AH | SE-Note 3 |
| Number of lead acid
batteries (gel or dry
acid) | None | 2 | Not available | Not applicable. Subject
device does not have
gel or dry acid batteries.
Hence the risk
associated with the gel
or dry acid in the
subject device is
eliminated
Also see SE-Note 3 |
| Battery type and
number of batteries
(pack) | Lithium-ion
number of batteries: 1 | Dry lead acid (non-spillable)
number of batteries: 2 | Lithium-ion | SE-Note 3 |
| | | | | |
| | Type: off-board | Type: off-board | Type: off-board | SE-Note 3 |
| Charger | Rated DC output voltage: 24.9V DC | Rated voltage output: 24V DC | Rated DC output voltage: 24V DC | |
| | Rated current output: 2.4A DC | Rated current output: 6A DC | Rated current output: 2A DC | |
| | Lithium-ion | Lead-acid | Lithium-ion | SE- Note 3 for primary
predicate |
| Battery Type | | | | Same as the Reference
Device 1 |
| Battery weight | 6.0 lbs. | 32.2 lbs. (per battery) | 17.6 lbs. (8 kg) | |
| OPERATING CHARACTERISTICS | | | | |
| Operating
environments | Indoor/outdoor uses | Indoor/outdoor uses | Not available | Same |
| Maximum Weight
Capacity | 300lb (136kg) | 220lb (100 kg) | 220lb (100 kg) | SE-Note 5 to primary
predicate
-Same as Reference
Device 1 |
| Maximum forward
speed (maximum safe
speed) | 5 mph | 5.5 mph | 3.8 mph (6.2 Km/hr.) | SE-Note 4 |
| Braking System | Electromagnetic | Electromagnetic | Electromagnetic | Same |
| Braking mechanism in
case of electrical
Brake Failure | Normally closed brakes
(The "normally closed" brakes are by default
engaged on the motors, preventing rotation, when
the device is powered off or when electrical power
is lost. Detailed description of braking system is
provided in Vol 10- Device description, Pg 24. | Normally closed brakes
(The "normally closed" brakes are by
default engaged on the motors,
preventing rotation, when the device is
powered off or when electrical power is
lost. Detailed description of braking
system is provided in | Not available | Both the subject and
predicate devices uses
the same operating
principle during an
electric brake failure. |
| Minimum braking
distance from max
speed | 1500 mm (1.5 m) | 1400 mm (1.4 m) | Not available | The braking distance
depends on the motor
controller design and
the maximum weight
capacity. The difference
between subject device
and predicate device is
negligible (only 10cm)
and mainly due to the
subject's device's higher
weight capacity (136kg
vs 100kg). Both devices
comply with ISO 7176-3
Requirements. The
difference does not |
| | | | | raise any safety or
effectiveness issues. |
| Turning Radius | 30" | 28" | Not available | SE-Note 1 |
| Obstacle Climbing
Height (Highest curb
clearance) | 2" | 3" | 1.96" (50 mm) | SE-Note 1 |
| Drive system | 2 Wheel Drive (Rear wheel drive) | All Wheel Drive | 2 Wheel Drive (Rear wheel drive) | SE-Note 6
-Same as Reference
Device 1 |
| Dynamic Stability
(maximum safe
operational incline in
degrees with highest
center of gravity) | Measured posteriorly: 10º
Measured anteriorly: 10º
Measured sideways: 10º | Measured posteriorly: 10º
Measured anteriorly: 10º
Measured sideways: 10º | Not available | Same |
| Driving Range (full
battery charge)/
Maximum distance
on fully battery
charge | 11 miles | 12 miles | 17.18 miles (27.65 km) | SE-Note 5 |
| On/Off Button | Yes, Power Button on the control pad. | No, Mode Switch (pull away or towards
the user) located on the opposite device
arm | Not available | Better operability in the
subject device. |
| Speed Settings | 4 | 3 | Not available | SE-Note 4 |
| Speed Limit | All the speed settings are in fall within the high
control speed limit of 5 mph
Detailed information is the Vol 10-Device
Description, pg.16, Table 6 | Low: Not measured
Medium: Not measured
High: 5.5 mph | Not available | |
| Battery Charging
Time | ~5 hours | 8 hours to 80% | 68 hours | The subject device's
battery charges faster |
| DESIGN FEATURES | | | | |
| Motor | Brushless DC motor (2 pcs)
Rated output: 150W each | Brushed DC motor (2 pcs)
Rated output: 800W each | Rated output: 24V 200W | SE-Note 7 |
| Motor controller | Manufacturer: WHILL
Model: 21-00011-0 | Manufacturer: PG Drives Technology
Model: R-Net PM120 | PG VR2 60A | SE-Note 7 |
| Joystick Location | Left or right arm | Left or right arm | Left or right arm | Same |
| Joystick | Users can select the WHILL mouse controller,
WHILL easy-grip controller, or a Body point
controller | Users can select the WHILL mouse
controller, WHILL easy-grip controller, or
a Body point controller | Not available | Same |
| User control interface | User controls are housed in a single component—
the control pad subassembly. The control pad
subassembly may be placed on either the right- or
left-hand side of the device to match the user's
preference.

The control pad subassembly contains the input
elements shown below.

1 Speed select button “ - “
Decreases the maximum speed.

2 Power button
Turns on/off the device.

3 Sound button
Turns on/off the sound.

4 Joystick
Controls the forward, backward, left, and right
movements. The degree of joystick inclination
can also control acceleration and deceleration.

5 Speed select button “+”
Increases the maximum speed.

6 Display | User controls are separated into two
components: directional controller
subassembly and indicator
subassembly—one subassembly for each
hand.

The indicator subassembly houses a
mode switch knob that can switch the
device on/off or into a low, medium, or
high-speed profile, indicated by visual
markings on the subassembly.

Table 4 Comparison of Model C2 with primary predicate (K153543) and Reference Device 1 (K182576)

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Comparison with Reference Device 2

The subject device includes an additional Radio Frequency wirere the device can be controlled with a smartphone app, supported on iOS, Android, via Bluetooth Low Energy (BLE). To account for the additional feature, e-motion-M25(K192618) is chosen as the reference device 2. Table 2 demonstrates that the Radio Frequency wireless technology in the subject device are substantially equivalent.

Table 5 Comparison of Model C2 with reference device 2 (K192618)

Radio Frequency Wireless Technology
Features	Reference Device 2
e-motion M25(K192618)	Subject Device
WHILL Model C2	Remark
Product Code	ITI	ITI	Same
Product Classification	Class II	Class II	Same
Indications for Use	The e-motion M25 is a Power Assist
Wheelchair Conversion Kit and suitable for
manual wheelchair users who are limited in
their field of activities because of their physical	The intended use of the Model C2 powered wheelchair
is to provide outdoor and indoor mobility to persons
limited to a seated position that is capable of
operating a powered wheelchair.	SE Note 10

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| | conditions. The device can expand its field of
activities by assisting its wheelchair operating
force | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Classification Name | Powered Wheelchair | Powered Wheelchair | Same |
| Regulation Number | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Type of wireless technology | IEEE 802.15.4 (Bluetooth Low Energy) | IEEE 802.15.4 (Bluetooth Low Energy) | Same |
| FCC compliance | CFR47, Part 15 | CFR47, Part 15 | Same |
| Wireless Coexistence
Compliance | ANSI C63.27-2017 American National Standard
for Evaluation Of Wireless Coexistence | ANSI C63.27-2017 American National Standard for
Evaluation Of Wireless Coexistence | Same |
| EMC Compliance | ISO 7176-21:2009 | ISO 7176-21:2009 | Same |
| Wireless functions | Emergency stop, Operating mode
(on/standby) | adjust speed, acceleration, turning settings, and lock
the device when it is unattended | Similar. Subject device has
additional features that
does not affect its safety
and effectiveness |
| Smartphone App | iOS and Android | iOS and Android | Same |
| Wireless RF frequency range | 2.402 GHz to 2.480 GH | 2.402 GHz to 2.480 GH | Same |
| Wireless RF maximum output
power | 5dBm | 6dBm | Minor difference. It does
not affect the subject
devices functionality |
| Wireless operating range | 10m | 10m | Same |

Note 1: "Device weight," "turning radius" "Obstacle Climbing Height" comply with ISO 7176-5 Wheelchairs Part 5: Determination of dimensions, mass, and maneuverings space
Note 2: The difference in "wheel diameters" does not affectiveness. The subject primary, and reference device 1 have passed the same criteria ("criteria) determined by EN 12184:2014 Electrically powered wheelchairs, scooters, and chargers.
Note 3 Battery, Battery charger:
- Battery lithium-ion batteries are used in the subject device over the lead-acid batteries in the predicate device. The batteries have passed the testing to IEC 62133-2:2017 (Secondary Cells and Batteries containing Alkaline or other Non-Acid Electrolytes – Safety Requirements for Portable Sealed Secondary Cells, and Batteries made from them, for use in Portable Applications),(Table 3) AND the subject device was tested to the ISO 7176 standard (Table 1)
- Battery Charger: Although the chargers are the same type of off-board chargers and possess the same input and slightly . different output voltages, IEC 60335-2-29:2016 Household and Similar Electrical Appliances - Safety - Particular Requirements for Battery Chargers

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Note 4 "Maximum speed forward" and "speed settings" comply with ISO 7176-6 Wheelchairs Part 6: Determination of maximum speed, acceleration, and deceleration of electric wheelchairs
Note 5 "Energy consumption," "Driving Range," and "Maximum capacity" comply with ISO 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
Note 6 "Drive System" complies ISO 7176-14 Wheelchairs Part 14: Power and control systems for electrically powered wheelchairs and scooters. Requirements and test methods.
Note 7 Motor and Motor controller
- Motors: The subject device uses Brushes DC motors over brushed DC motors to achieve lightweight and portability. Please see Table 6 for the comparison

Features	Model M: R-net module	Model C2: WHILL motor controller
Compatible motor type	Brushed DC motors	Brushless DC motors
	- heavy	- lightweight
	- bulky	- compact
	- low cost	- high cost
	- simple control mechanism	- sophisticated control mechanism
Optimization	Difficult to adjust for WHILL devices due to minimal motor control parameters	Fully optimizable to match WHILL device characteristics

Table 6 Comparison of Brushless DC Motors over Brushed DC Motors

Motor controller: WHILL Motor controller is used over R-Net power module. The motor controller. The motor . and the motor controller comply with ISO 7176-14 Wheelchairs – Part 14: Power and control systems for electrically powered wheelchairs and scooters. Requirements and test methods
Note 8: The difference in the device materials does not affectiveness of the device. The subject device has been tested to Flammability per ISO 8191-2:1988 Furniture — Assessment of igniture — Part 2: Ignition source: match-flame equivalent, a normative reference in EN 12184:2014 Electrically powered wheelchairs, scooters, and chargers.
Note 9: The difference in environmental conditions comes from the different battery types used in the primary predicate. These differences do not affect the subject device's safety and effectiveness
Note 11: The rationale for the subject device meeting the OTC designation with the Primary Predicate Device is as follows:

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1. The indication of Model C2 does not require a physician's diagnosis.
- . Neither Model C2 nor Model M was indicated for any specific disease that requires a physician's diagnosis.
1. The use of Model C2 does not involve a physician or Healthcare professional's (HCP) intervention.
- Neither Model C2 nor Model M requires an HCP to train the user. .
- . Neither Model C2 or Model M's IFU contains warnings that require an HCP's intervention or consultation.
- The Model C2 IFU is designed to be self-sufficient in training and guiding users in safe and effective use of the subject device and is shown to be adequate as the sole instructional material of the non-prescriptive Model C2 device in Japan.
1. The maximum weight capacity of Model C2 has been increased to 300lbs from Model M's 220lbs to accommodate a wider patient population on par with most wheelchairs on the market without the need for physician's screening.

The rationale for the subject device meeting the OTC designation with Reference Device 1 (K182576) is as follows:

1. Neither the subject device nor Reference Device 1 requires a physician's diagnosis. Both devices are indicated for the same patient population without specific disease conditions.
1. Neither device involves a physician or HCP's intervention.
Both devices share highly similar technological features and performance specifications as shown in Table 1. The justification 3. for the only notable feature difference of device disassembly is documented in Note 15 below and this feature has been verified and validated to ensure that all new risks are mitigated.
Note 12: The tie downs were removed from Model C2, because the wheelchair is not intended to be used in a motor vehice. The removal of the tie downs eliminates the risk of foreseeable misuse. The Model C2 IFU contains a warning against the use of the device as a seat in a motor vehicle.
Note 13: Although Model C2 does not have dedicated pressure relief handles as the predicate device, both arm supports on Model C2 are capable of being used for the same purpose. The arm support has been test ID# TCL02-W-036 to withstand 1076N of downward force repeatedly for 20,000 cycles. 1076N is the max load capacity of Model C2. The test demonstrates that Model C2 users may use the either one or both arm supports for pressure relief
Note 14: The seat slide feature was removed from Model C2 to eliminate the risk of foreseeable misuse from an unstable extended seat, the pinch point hazard or the collision hazard of a retracting seat.
Note 15: The primary predicate device (M) cannot be disassembled, making it difficult for transportation. The subject device on the other hand can be disassembled into 4 transportable parts. The wheelchair in the subject device allows for smaller storage and easy transportation space, which is easier, safer and convenient for Model C2 users. These differences in wheelchair disassembly in predicate device and subject device does not impact the safety and effectiveness of the device.

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The difference from the reference device 2

Note 10 indication for use is different, but the primary indication is to assist users with mobility. The subject device has a wireless functionality to control the device with the same technological means as the reference device 2. Hence both the subject and the reference 2 devices are considered substantially equivalent concerning the aspects of RF Wireless technology.

XII. CONCLUSIONS

The July 28, 2014 FDA Guidance entitled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (510(k)" was used to determine substantial equivalence. The WHLL Model C2 (Subject Device) described herein has an equivalent intended use and the same fundamental technology as the cleared primary predicate device, the WHILL Model M (K153543), and the reference device 1, Solax Powered Wheelchair (K182576). The additional wireless technology feature is comparable to the reference device 2, the e-motion-M25 (K192618). Based on the performance data presented for the design differences between the subject device and primary predicate device, it can be concluded that the WHILL Model C2 is as safe and effective as, and substantially equivalent to, the predicate device and reference devices.