Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard power wheelchair with no mention of AI or ML components, image processing, or data sets for training/testing. The performance studies focus on standard wheelchair safety and performance metrics.

Therapeutic

No
A therapeutic device is used to treat or prevent disease. This device is a power wheelchair, which is a mobility aid, not a treatment for any disease or condition.

Diagnostic

No.
The power wheelchair is described as a transportation vehicle for mobility, not for diagnosis of any medical condition. Its intended use and device description focus on assisting mobility, and the performance studies confirm its safety and functionality as a mobility aid.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components (front wheel, drive wheel, frame, controller, motor, armrest, push-handle, backrest, seat cushion, footrest, battery box, and charger) and the performance studies focus on the physical characteristics and safety of the 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 clearly stated as providing mobility to a disabled or elderly person. This is a physical assistance device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The description details the components of a power wheelchair, all of which are related to physical movement and transportation. There are no components or functions related to analyzing biological samples.
Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers

The device is a mobility aid, falling under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Power Wheelchair (N5909) is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Product codes

ITI

Device Description

This Power wheelchair, N5909, is a motor driven, indoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties.

The device consists of front wheel, drive wheel, frame, controller, motor, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.

The device is powered by a Li-ion Battery pack (24V 10Ah, 240Wh) with 10 Km (6 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

disabled people with mobility difficulties and elderly people / indoor and outdoor use

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)

Performance testing-bench A: The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.

. Risk Analysis developed in accordance with ISO 14971:2019.
. Software validation
. ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
ISO 7176-3:2012 Wheelchairs Part 3: Determination of effectiveness of brakes ●
ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs . and scooters for determination of theoretical distance range
. ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
. ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
. ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
. ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength
. ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
. ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
. ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
. ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.
. ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
. ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
. ISO 16840:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
. ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
. ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
. ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs
. Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.

Biocompatibility of patient-contacting material: Biocompatibility Tests are carried out in accordance with ISO 10993-1: 2018, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).

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

Braking distance: ≤1.5 m
Turning Radius: 900 mm
Maximum obstacle climbing: 40 mm
Maximum safe operational incline degree: 9 degrees
Max speed forward: Up to 6 km/h (1.68 m/s), adjustable
Max Speed backward: 0.71 m/s (2.556 km/h)
Max loading weight: 110kg (~250lbs)

Predicate Device(s)

K220747

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

December 13, 2023

Zhejiang Innuovo Rehabilitation Devices Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K230964

Trade/Device Name: Power Wheelchair (N5909) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 9, 2023 Received: November 9, 2023

Dear Ivy Wang:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices

2

OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K230964

Device Name Power Wheelchair (N5909)

Indications for Use (Describe)

The Power Wheelchair (N5909) is a motor driven. indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

510(k) Summary

K230964

SUBMITTER l.

Name: Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

Address: No.196 Industry Road, Hengdian Movie Zone, Donqyang, Zhejiang, China

Name of contact person: Grace Li

Telephone: +86 15924234767

Fax: +86-579-89327232

Email: Lss@kf-innuovo.com

Date prepared: 2023-11-012

II. Device

Device trade name: Power Wheelchair

Model: N5909

Regulatory Information:

Classification name: Powered wheelchair

Regulation class: 2

Regulation number: 21CFR 890.3860

Panel: Physical Medicine

Product code: ITI

III. Predicate device

K220747

Power Wheelchair, N5515B

Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

IV. Device description

This Power wheelchair, N5909, is a motor driven, indoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties.

The device consists of front wheel, drive wheel, frame, controller, motor, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.

5

The device is powered by a Li-ion Battery pack (24V 10Ah, 240Wh) with 10 Km (6 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

V. Indication for use

The Power Wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

| Attribute | Subject device | Predicate device | Discussion/
Conclusion |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Zhejiang Innuovo
Rehabilitation Devices
Co., Ltd. | Zhejiang Innuovo
Rehabilitation Devices Co.,
Ltd. | / |
| Proprietary name,
model | Power Wheelchair, N5909 | Power Wheelchair, N5515B | / |
| 510(k) number | K230964 | K220747 | / |
| Device classification
name | Class II | Class II | Same |
| Classification
regulations | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | Same |
| Similarities | | | |
| Indication for use | The Power Wheelchair is
a motor driven, indoor and
outdoor transportation
vehicle with the intended
use to provide mobility to a
disabled or elderly person
limited to a seated
position. | The Power Wheelchair is a
motor driven, indoor and
outdoor transportation
vehicle with the intended
use to provide mobility to a
disabled or elderly person
limited to a seated position. | Same |
| Intended user | disabled people with
mobility difficulties and
elderly people | disabled or elderly person
limited to a seated position | Same |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 4, including two front | 4, including two pivoting | Same |
| Attribute | Subject device | Predicate device | Discussion/ Conclusion |
| | wheels and two rear wheels | casters and two rear drive wheels | |
| Function of wheels | Front wheels: driven wheels suitable for rotation, acceleration, retrograde
Rear wheels: driving wheels to control the speed and direction | two pivoting casters: driven wheels suitable for rotation, acceleration, retrograde
two rear drive wheels: driving wheels to control the speed and direction | Same |
| Movement control method | By Joystick control | By Joystick control | Same |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Brake system | Automatic electromagnetic brake system | Intelligent regenerative Electromagnetic brake | Same |
| Braking distance | ≤1.5 m | ≤1.5 m | Same |
| Main frame material | Carbon fiber material | Carbon fiber material | Same |
| back cushion | Polyester fabric | Polyester fabric | Same |
| Turning Radius | 900 mm | 900 mm | Same |
| Maximum obstacle climbing | 40 mm | 40 mm | Same |
| Maximum safe operational incline degree | 9 ° | 9 ° | Same |
| Battery charger | Off-board charger
Input: 100-240V, 50/60Hz, 1.5A,
Output: 24 Vdc, 2A; | Off-board, Automatic Type
Input: 110-220 V / 50-60 Hz,
Output: 24 Vdc, 2A; | Same |
| Front wheel size/type | 7" x 1.5"/PU Solid tire | 7" x 1.5"/PU Solid tire | Same |
| Rear wheel size/type | 8.5"x 1.8"/ PU Solid tire | 8.5"x 1.8"/ PU Solid tire | Same |
| Differences | | | |
| Battery | li-ion battery pack; rechargeable, 24 VDC 10Ah | li-ion battery pack; rechargeable, 24 VDC 10Ah 2pcs | the battery capacity will impact the travel distance, which will not cause new safety and effectiveness concerns raised. |
| Maximum distance of travel on the fully charged battery | 10 km | 20 km | Shorter driving distance will not cause new safety and effectiveness |
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
| seat cushion | Polyester fabric | rubber patch cloth and Oxford fabric | different material used for parts in contact with user, which such differences will not impact the safety and effectiveness of the subject device as biocompatibility tests are carried out according to ISO 10993 series. |
| Armrest | T700 | PU | Different material used for parts in contact with user, which such differences will not impact the safety and effectiveness of the subject device as biocompatibility tests are carried out according to ISO 10993 series. |
| Overall Dimension (lengthwidthheight) | 900mmX580mmX860mm | 940mmX610mmX960mm | Minor difference on wheelchair dimension will not cause different performance. All safety and performance have been validated with the maximum rated weight dummy. |
| Stowage Dimension (lengthwidth*height) | 900mmX250mmX860mm | 720mmX310mmX610mm | |
| Folding method | Collapsible cross-brace | Foldable seat frame | Different folding method will not cause different performance. No safety or effectiveness concerns raised. |
| Max speed forward | Up to 6 km/h (1.68 m/s), adjustable | Up to 6 km/h (1.6 m/s), adjustable | minor difference on max. forwarding speed will not cause different performance. |
| Max Speed backward | 0.71 m/s (2.556 km/h) | 0.5 m/s (1.8 km/h) | minor difference on max. backward speed will not cause different performance. |

VI. Comparison of technological characteristics with the predicate device

6

7

8

--------------------	-----------------	-----------------	--------------------------------------------------------------------------

9

| Attribute | Subject device | Predicate device | Discussion/
Conclusion |
|-----------------------|------------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Lower loading weight
provide less pressure to
the chair and easy for the
transportation. |
| Electronic controller | ELECTRIC
WHEELCHAIR
CONTROL SYSTEM | ELECTRIC WHEELCHAIR
CONTROL SYSTEM | Similar controller is used,
both the control system,
including the joystick
controller, the
electromagnetic brakes
and the user interface are
similar. The joystick
controls the directions
and speed of movement,
and when the joystick is
released, the powered
wheelchair will slow down
to stop and the brakes will
automatically re-engage.
The controller also
provides the battery
status displaying and
abnormal condition
displaying. Both of the
control systems are
evaluated according to
standard ISO
7176-14:2008 and
software validation
requirement and there
are no new safety and
effectiveness concerns
due to the difference. |
| Motor | Brushless DC motor;
24VDC; 150W; 2pcs | Brushless DC motor;
24VDC; 250W; 2pcs | minor difference on motor
power will not cause
different performance. No
safety or effectiveness
concerns raised. |

VII. Summary of substantial equivalence discussion

The power wheelchair complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2017,

ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998,

ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2012, ISO

10

7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 16840-10:2021, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2014, ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2010.

The intended uses for both devices are the same. Mainframes of the two devices are foldable, and the frame materials are the same carbon fiber. The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14:2008. Software validation is carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012. Folding method are different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns. The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2010.

The flame retardant test of the seat cushion/backrest of the subject device is conducted according to ISO 16840-10, while the predicate device is carried out according to the ISO 7176-16 test. Both of the two testing methods are recognized consensus standards for flammability resistance. Therefore, both devices are assured to be under the same safety level.

In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

VIII. Summary of non-clinical testing

Performance testing-bench A

The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.

. Risk Analysis developed in accordance with ISO 14971:2019.
. Software validation
. ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs

11

ISO 7176-3:2012 Wheelchairs Part 3: Determination of effectiveness of brakes ●
ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs . and scooters for determination of theoretical distance range
. ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space
. ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
. ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
. ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength
. ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
. ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
. ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies
. ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces.
. ISO 7176-14:2008 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters -- Requirements and test methods
. ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
. ISO 16840:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
. ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
. ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
. ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs
. Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.

A Biocompatibility of patient-contacting material

Biocompatibility Tests are carried out in accordance with ISO 10993-1: 2018, including

12

cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).

IX. Summary of clinical testing

No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electric wheelchair to its predicate device.

X. Conclusions

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K220747.