WHILL Model C2

K213383 · Whill, Inc. · ITI · Nov 9, 2021 · Physical Medicine

Device Facts

• Record ID: K213383
• Device Name: WHILL Model C2
• Applicant: Whill, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Nov 9, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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.

Device Story

WHILL Model C2 is a battery-operated, 2-wheel rear-drive powered wheelchair for indoor/outdoor mobility. Input: user-operated joystick on armrest or smartphone app via Bluetooth Low Energy (BLE). Transformation: joystick/app signals processed by electric motor controller to drive brushless DC motors; electromagnetic brakes engage upon joystick release. Output: powered movement; smartphone app displays battery status, speed/acceleration settings, and remote lock/unlock. Used in home/community settings by patients capable of operating controls. Healthcare providers do not intervene in operation. Benefits: provides mobility for seated users; modular design allows disassembly into four parts for transport. Safety features include electromagnetic braking and speed/acceleration limits.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated through bench testing, including ISO 7176 performance standards (stability, braking, energy consumption, dimensions, speed, fatigue strength, climatic tests, obstacle climbing), biocompatibility (ISO 10993), electrical safety (IEC 60601-1-2, IEC 62368-1), and wireless coexistence (ANSI C63.27).

Technological Characteristics

Solid aluminum frame; 2-wheel rear-drive; brushless DC motors; 25.3V 10.6Ah lithium-ion battery; electromagnetic braking; Bluetooth Low Energy (BLE) connectivity. Dimensions: 38.8" L x 21.8" W. Max weight capacity 136kg (300lbs). Max speed 5mph. Non-sterile. Software: moderate level of concern.

Indications for Use

Indicated for indoor and outdoor mobility for persons limited to a seated position capable of operating a powered wheelchair.

Regulatory Classification

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.

Predicate Devices

• WHILL Model M (K153543)

Reference Devices

• Solax Powered Wheelchair (K182576)
• e-motion M25 (K192618)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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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# 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: [phone] |
| | | 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

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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.

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- 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

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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."

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| Subject Device<br>WHILL Model C2 | Primary Predicate Device<br>WHILL Model M (K153543) | Reference Device 1<br>Solax Powered Wheelchair<br>(K182576) | Reference Device 2<br>e-motion M25 (K192618) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 7176-1 Third edition<br>2014-10-01 Wheelchairs -<br>Part 1: Determination of<br>static stability | American National Standard for Wheelchairs -<br>RESNA Volume 1: Requirements and Test Methods<br>for Wheelchairs (Including Scooters) Section 1<br>Determination of Static Stability | ISO 7176-1: 2014, Wheelchairs -<br>Part 1: Determination of static<br>stability | ISO 7176-1 Wheelchairs - Part 1:<br>Determination of static stability |
| ISO 7176-2 Third edition<br>2017-10 Wheelchairs - Part<br>2:Determination of dynamic<br>stability of electrically<br>powered wheelchairs | American National Standard for Wheelchairs -<br>Volume 2: Additional Requirements for<br>Wheelchairs (Including Scooters) With Electrical<br>Systems Section 2: Determination of Dynamic<br>Stability of Electrically Powered Wheelchairs | ISO 7176-2 Wheelchairs - Part 2:<br>Determination of dynamic stability<br>of electric wheelchairs | ISO 7176-2 Wheelchairs – Part 2:<br>Determination of dynamic stability of<br>electric wheelchairs |
| ISO 7176-3 Third edition<br>2012-12-15 Wheelchairs -<br>Part 3: Determination of<br>effectiveness of brakes | American National Standard for Wheelchairs -<br>Volume 2: Additional Requirements for<br>Wheelchairs (Including Scooters) With Electrical<br>Systems Section 3: Determination of Effectiveness<br>of Brakes | ISO 7176-3: 2012, Wheelchairs - Part<br>3: Determination of effectiveness of<br>brakes | ISO 7176-3 Wheelchairs - Part 3:<br>Determination of efficiency of brakes |
| ISO 7176-4 Third edition<br>2008-10-01Wheelchairs -<br>Part 4: Energy consumption<br>of electric wheelchairs and<br>scooters for determination<br>of theoretical distance<br>range | American National Standard for Wheelchairs -<br>Volume 2: Additional Requirements for<br>Wheelchairs (Including Scooters) With Electrical<br>Systems Section 4: Energy Consumption of<br>Electrically Powered Wheelchairs and Scooters for<br>Determination of Theoretical Distance | ISO 7176-4, Third edition 2008-10-<br>01, Wheelchairs - Part 4: Energy<br>consumption of electric wheelchairs<br>and scooters for determination of<br>theoretical distance range | ISO 7176-4 Wheelchairs – Part 4: Energy<br>consumption of electric wheelchairs and<br>scooters for determination of theoretical<br>distance range |
| ISO 7176-5 Second edition<br>2008-06-01Wheelchairs -<br>Part 5: Determination of<br>overall dimensions, mass<br>and maneuvering space | American National Standard for Wheelchairs -<br>Volume 1: Requirements and Test Methods for<br>Wheelchairs (Including Scooters) Section 5:<br>Determination of Dimensions, Mass and<br>Maneuvering Space | ISO 7176-5, Second edition 2008-06-<br>01, Wheelchairs - Part 5:<br>Determination of overall dimensions,<br>mass and maneuvering space | ISO 7176-5 Wheelchairs – Part 5:<br>Determination of dimensions, mass, and<br>maneuvering space |
| Subject Device<br>WHILL Model C2 | Primary Predicate Device<br>WHILL Model M (K153543) | Reference Device 1<br>Solax Powered Wheelchair<br>(K182576) | Reference Device 2<br>e-motion M25 (K192618) |
| ISO 7176-6 Third edition<br>2018-06 Wheelchairs - Part<br>6: Determination of<br>maximum speed,<br>acceleration and<br>deceleration of electric<br>wheelchairs | American National Standard for Wheelchairs -<br>Volume 2: Additional Requirements for<br>Wheelchairs (Including Scooters) With Electrical<br>Systems Section 6: Determination of Maximum<br>Speed, Acceleration and Deceleration of<br>Electrically Powered Wheelchairs | ISO 7176-6: 2001, Wheelchairs - Part<br>6: Determination of maximum<br>speed, acceleration and deceleration<br>of Powered Wheelchairs | ISO 7176-6 Wheelchairs – Part 6:<br>Determination of maximum speed,<br>acceleration, and deceleration of electric<br>wheelchairs |
| ISO 7176-8 Second edition<br>2014-12-15 Wheelchairs -<br>Part 8: Requirements and<br>test methods for static,<br>impact and fatigue<br>strengths | American National Standard for Wheelchairs -<br>Volume 1: Requirements and Test Methods for<br>Wheelchairs (Including Scooters) Section 8:<br>Requirements and Test Methods for Static, Impact<br>And Fatigue Strengths | ISO 7176-8:2014, Wheelchairs - Part<br>8: Requirements and test methods<br>for static, impact and fatigue<br>strengths | ISO 7176-8 Wheelchairs – Part 8:<br>Requirements and test methods for static,<br>impact, and fatigue strengths |
| ISO 7176-9 Third edition<br>2009-11-15Wheelchairs -<br>Part 9: Climatic tests for<br>electric wheelchairs | American National Standard for Wheelchairs -<br>Volume 1: Requirements and Test Methods for<br>Wheelchairs (Including Scooters) Section 9:<br>Climatic Tests for Electrically Powered Wheelchairs | ISO 7176-9:2009, Wheelchairs - Part<br>9: Climatic tests for Powered<br>Wheelchairs | ISO 7176-9 Wheelchairs - Part 9: Climatic<br>tests for electric wheelchairs |
| ISO 7176-10 Second edition<br>2008-11 01Wheelchairs -<br>Part 10: Determination of<br>obstacle-climbing ability of<br>electrically powered<br>wheelchairs | American National Standard for Wheelchairs -<br>Volume 2: Additional Requirements for<br>Wheelchairs (Including Scooters) With Electrical<br>Systems Section 10: Determination of Obstacle-<br>Climbing Ability of Electrically Powered<br>Wheelchairs | ISO 7176-10:2008, Wheelchairs -<br>Part 10: Determination of obstacle-<br>climbing ability of electrically<br>powered wheelchairs | ISO 7176-10 Wheelchairs – Part 10:<br>Determination of obstacle-climbing ability<br>of electrically powered wheelchairs |
| ISO 7176-11 Second edition<br>2012-12-01Wheelchairs -<br>Part 11: Test dummies | American National Standard for Wheelchairs -<br>Volume 1: Requirements and Test Methods for<br>Wheelchairs (Including Scooters) Section 11: Test<br>Dummies | ISO 7176-11, Second edition 2012-<br>12-01, Wheelchairs - Part 11: Test<br>dummies | ISO 7176-11 Wheelchairs - Part 11: Test<br>Dummies |
| Subject Device<br>WHILL Model C2 | Primary Predicate Device<br>WHILL Model M (K153543) | Reference Device 1<br>Solax Powered Wheelchair<br>(K182576) | Reference Device 2<br>e-motion M25 (K192618) |
| ISO 7176-13: 1989<br>Wheelchairs - Part 13:<br>Determination of Coefficient<br>of Friction of Test Surfaces | American National Standard for Wheelchairs -<br>Volume 1: Requirements and Test Methods for<br>Wheelchairs (Including Scooters) Section 13:<br>Determination of Coefficient of Friction of Test<br>Surfaces | ISO 7176-13, First edition 1989-08-<br>01, Wheelchairs - Part 13:<br>Determination of coefficient of<br>friction of test surfaces | ISO 7176-13: 1989 Wheelchairs - Part 13:<br>Determination of Coefficient of Friction of<br>Test Surfaces |
| ISO 7176-14 Second edition<br>2008-02-15 Wheelchairs -<br>Part 14: Power and control<br>systems for electrically<br>powered wheelchairs and<br>scooters - Requirements<br>and test methods | American National Standard for Wheelchairs -<br>Volume 2: Additional Requirements for<br>Wheelchairs (Including Scooters) With Electrical<br>Systems Section 14: Power and Control Systems<br>for Electrically Powered Wheelchairs -<br>Requirements and Test Methods | ISO 7176-14:2008, Wheelchairs -<br>Part 14: Power and control systems<br>for electrically powered wheelchairs<br>and scooters - Requirements and<br>test methods | ISO 7176-14 Wheelchairs - Part 14: Power<br>and control systems for electrically<br>powered wheelchairs and scooters.<br>Requirements and test methods |
| ISO 7176-15 First edition<br>1996-11-15 Wheelchairs -<br>Part 15: Requirements for<br>information disclosure,<br>documentation and labeling | American National Standard for Wheelchairs -<br>Volume 1: Requirements and Test Methods for<br>Wheelchairs (Including Scooters) Section 15:<br>Requirements for information disclosure,<br>documentation, and labeling | ISO 7176-15:1996, Wheelchairs -<br>Part 15: Requirements for<br>information disclosure,<br>documentation and labeling | ISO 7176-15 Wheelchairs – Part 15:<br>Requirements for information disclosure,<br>documentation, and labeling |
| Subject Device<br>WHILL Model C2 | Primary Predicate Device<br>WHILL Model M (K153543) | Reference Device 1<br>Solax Powered Wheelchair<br>(K182576) | Reference Device 2<br>e-motion M25 (K192618) |
| ISO 7176-16 Wheelchairs –<br>Part 16: Resistance to<br>ignition of postural support<br>devices- ISO 8191-2:1988<br>Furniture — Assessment<br>of ignitability of<br>upholstered furniture —<br>Part 2: Ignition source:<br>match-flame equivalent | Cushions used are purchased components that are<br>FDA-listed and compliant with ISO 8191-1 and ISO<br>8191-2, covers are compliant with ISO 7176-16 | ISO 7176-16, Second edition 2012-<br>12-01, Wheelchairs - Part 16:<br>Resistance to ignition of postural<br>support devices | ISO 7176-16 Wheelchairs – Part 16:<br>Resistance to ignition of postural support<br>devices |
| ISO 7176-21 Second edition<br>2009-04-01Wheelchairs -<br>Part 21: Requirements and<br>test methods for<br>electromagnetic<br>compatibility of electrically<br>powered wheelchairs and<br>scooters, and battery<br>chargers | American National Standard for Wheelchairs -<br>Volume 2, Additional Requirements for<br>Wheelchairs (Including Scooters) With Electrical<br>Systems Section 21: Requirements and Test<br>Methods for Electromagnetic Compatibility of<br>Electrically Powered Wheelchairs and Motorized<br>Scooters | ISO 7176-21 Second edition 2009-<br>04-01 Wheelchairs - Part 21:<br>Requirements and test methods for<br>electromagnetic compatibility of<br>electrically powered wheelchairs and<br>scooters, and battery chargers | -ISO 7176-21 Wheelchairs – Part 21:<br>Requirements and test methods for<br>electromagnetic compatibility |
| ISO 7176-22 Second edition<br>2014-09-01 Wheelchairs -<br>Part 22: Set-up procedure | ANSI RESNA WC-1:2019 Section 22<br>American National Standard for Wheelchairs -<br>Volume 1: Requirements and Test Methods for<br>Wheels chairs (including Scooters) Section 22: Set-<br>up Procedures | ISO 7176-22 Second edition 2014-<br>09-01 Wheelchairs - Part 22: Set-up<br>procedures | Not Mentioned |
| UN 38.3 Recommendations<br>of the TRANSPORT OF<br>DANGEROUS GOODS,<br>Manual of Test and Criteria,<br>Part III, Lithium metal and<br>lithium-ion batteries | NA | NA | UN 38.3 Recommendations of the<br>TRANSPORT OF DANGEROUS GOODS,<br>Manual of Test and Criteria, Part III, Lithium<br>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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# 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<br>Medical Devices - Part 5: Tests For In Vitro<br>Cytotoxicity | Non- Cytotoxic | Pass |
| ISO 10993-10:2010 Biological Evaluation of<br>Medical Devices - Part 10: Tests for Irritation and<br>Skin Sensitization | Non-Sensitizing | Pass |
| ISO 10993-10:2010 Biological Evaluation of<br>Medical Devices - Part 10: Tests for Irritation and<br>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<br>Safety and Essential Performance - Collateral Standard: Electromagnetic<br>Disturbances - Requirements and Tests |
| IEC/EN 61000-3-2:2014 | Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic<br>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<br>changes, voltage fluctuations and flicker in public low-voltage supply<br>systems, for equipment with rated current ≤16 A per phase and not subject<br>to conditional connection |
| IEC/EN61000-4-2 Edition 2.0 2008-12, | Electromagnetic compatibility (EMC)- Part 4-2: Testing and measurement<br>techniques - Electrostatic discharge immunity test |
| IEC/EN61000-4-3 Edition 3.2 2010-04, | Electromagnetic compatibility (EMC)- Part 4-3: Testing and measurement<br>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<br>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<br>techniques - Surge immunity test |
| IEC/EN61000-4-6 Edition 4.0 2013-10, | Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement<br>techniques - Immunity to conducted disturbances, induced by radio-<br>frequency fields |
| IEC/EN61000-4-8 Edition 2.0 2009-09, | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement<br>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<br>techniques - Voltage dips, short interruptions and voltage variations<br>immunity tests |
| EN 61326-2-2:2013 | Electrical equipment for measurement, control and laboratory use. EMC<br>requirements. Particular requirements. Test configurations, operational<br>conditions and performance criteria for portable test, measuring and<br>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<br>services; Part 1: Common technical requirements; Harmonized Standard for<br>Electromagnetic Compatibility |
| ETSI EN 300 328 V2.2.2 (2019-07) | Wideband transmission systems; Data transmission equipment operating in<br>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<br>products |
| IEC 62133-2 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline or other non-acid<br>electrolytes - Safety requirements for portable sealed secondary cells, and<br>batteries made from them, for use in portable applications - Part 2: Lithium<br>systems |
| IEC 60335-2-29:2016 | Safety of household and similar electrical appliances Part 2-29: Requirements<br>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<br>WHILL Model C2 | Primary Predicate Device<br>WHILL Model M (K153543) | Reference Device 1<br>Solax Powered Wheelchair, model: S7102<br>(K182576) | Remark |
|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Whill, Inc. | Whill, Inc. | Dongguan Prestige Sporting Goods Co., Ltd | Same |
| 510K Number | Unknown | K153543 | K182576 | - |
| Common or Usual<br>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<br>wheelchair is to provide outdoor and indoor<br>mobility to persons limited to a seated position<br>that are capable of operating a powered<br>wheelchair. | The intended use of the Model M<br>powered wheelchair is to provide<br>outdoor and indoor mobility to persons<br>limited to a seated position that are<br>capable of operating a powered<br>wheelchair. | The intended use of Solax Powered<br>wheelchair is to provide mobility to adults,<br>limited to a seated position that have<br>capability to operate a few simple controls<br>and the ability to control a powered<br>wheelchair. | -Same as the primary<br>predicate<br>-Similar to Reference<br>Device 1. The primary<br>indication of the subject<br>and the Reference<br>Device 1 is to assist<br>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<br>primary predicate<br>device<br>-Same as the Reference<br>Device 1 |
| Device Length | 38.8" | 37"- 42" (depending on foot<br>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"…