Electrically powered wheelchair (HP202)

• K Number: K241337
• Device Name: Electrically powered wheelchair (HP202)
• Manufacturer: Kunshan Hi-Fortune Health Products Co., Ltd
• Date Cleared: 2024-10-17 ( 157 days)
• Product Code: ITI
• Regulation Number: 890.3860

Intended Use

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

Device Description

The Electrically powered wheelchair 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 and elderly people. It is mainly composed of front wheel, drive wheel, frame, controller (joystick), motor and drive devices, armrest, backrest, seat belt, footrest, battery box and charger. The device is powered by Li-ion Battery pack (25V 10Ah) with 11.8 Km 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 user can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. When the user releases the joystick will automatically go 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.

Predicate Devices

K230964

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard electrically powered wheelchair with a joystick control and electromagnetic brake system, with no mention of AI/ML capabilities or related components like sensors for autonomous navigation or object detection.

Therapeutic

Yes
The device is described as assisting "disabled or elderly person limited to a seated position" and "action handicapped people and disabled people to move," which implies a medical purpose of alleviating disability and providing mobility.

Diagnostic

No
The device is described as an electrically powered wheelchair, which is a transportation vehicle for mobility, not a device used to identify, monitor, or diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including wheels, frame, motor, battery, and charger, indicating it is a physical device, not software only.

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 function, not a diagnostic test performed on biological samples.
• Device Description: The description details a mechanical and electrical device for transportation, not a device for analyzing biological specimens.
• Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other components typically associated with IVD devices.
• Performance Studies: The performance studies focus on the physical and electrical characteristics of the wheelchair (stability, speed, battery life, etc.), not on the accuracy or reliability of a diagnostic test.

Therefore, this device is a medical device intended for mobility assistance, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

ITI

Device Description

The Electrically powered wheelchair 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 and elderly people.

It is mainly composed of front wheel, drive wheel, frame, controller (joystick), motor and drive devices, armrest, backrest, seat belt, footrest, battery box and charger.

The device is powered by Li-ion Battery pack (25V 10Ah) with 11.8 Km 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 user can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. When the user releases the joystick will automatically go 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

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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

• ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
• ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And > Skin Sensitization
• ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for irritation >

• ISO 7176-1: 2014. Wheelchairs - Part 1: Determination of static stability

• ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of Powered Wheelchairs

• ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes >

• ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and wheelchairs for determination of theoretical distance range

• ISO 7176-5, Second edition 2008-06-01, Wheelchairs Part 5: Determination of overall > dimensions, mass and manoeuvring space

• ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs

• ISO 7176-7, 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 strengths

• ISO 7176-9:2009, Wheelchairs Part 9: Climatic tests for Powered Wheelchairs >
• ISO 7176-10:2008, Wheelchairs Part 10: Determination of obstacle-climbing ability of > electrically powered wheelchairs
• ア ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies.

• ISO 7176-13, First edition 1989-08-01, 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 wheelchairs - Requirements and test methods

• ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling

• ISO 16840-10:2021 Wheelchair seating Part 10: Resistance to ignition of postural support devicesRequirements and test method.

• ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers

• ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered wheelchairs >

• IEC 62133-2: 2017: Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

No clinical study is included in this submission.

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

Not Found

Predicate Device(s)

K230964

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 17, 2024 Kunshan Hi-Fortune Health Products Co., Ltd % Ariel Xiang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China

Re: K241337

Trade/Device Name: Electrically powered wheelchair (HP202) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 16, 2024 Received: September 16, 2024

Dear Ariel Xiang:

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.

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"

1

K241337 - Ariel Xiang

(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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

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

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

For comprehensive regulatory information about 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 ([e-mail]) or phone [phone] or 301-796-7100).

2

Sincerely,

Tushar Bansal -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241337

Device Name

Electrically powered wheelchair

Indications for Use (Describe)

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

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 K241337

Document Prepared Date: 2024/5/11

Applicant: A. Kunshan Hi-Fortune Health Products Co., Ltd Address:NO.625 Juxiang Road, Zhangpu Town.Kunshan City, Jiangsu ,215321, CHINA Contact Person: Lewis Tian Email:[e-mail]

Submission Correspondent: Primary contact: Ms.Ariel Xiang Title: Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

Secondary contact: Mr. Jarvis Wu Title: Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

B. Device:

Trade Name: Electrically powered wheelchair Common Name: Powered wheelchair Models: HP202

Regulatory Information Classification Name: Powered wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine

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C. Predicate device:

510(k) number: K230964 Regulation Number: 890.3860 Classification Name: Powered wheelchair Device Name: Power Wheelchair Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

D. Indications for use of the device:

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

E. Device Description:

The Electrically powered wheelchair 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 and elderly people.

It is mainly composed of front wheel, drive wheel, frame, controller (joystick), motor and drive devices, armrest, backrest, seat belt, footrest, battery box and charger.

The device is powered by Li-ion Battery pack (25V 10Ah) with 11.8 Km 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 user can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. When the user releases the joystick will automatically go 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.

Non-Clinical Test Conclusion F.

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

• ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
• ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And > Skin Sensitization
• ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for irritation >

• ISO 7176-1: 2014. Wheelchairs - Part 1: Determination of static stability

• ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of Powered Wheelchairs

• ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes >

• ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and wheelchairs for determination of theoretical distance range

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• ISO 7176-5, Second edition 2008-06-01, Wheelchairs Part 5: Determination of overall > dimensions, mass and manoeuvring space

• ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs

• ISO 7176-7, 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 strengths

• ISO 7176-9:2009, Wheelchairs Part 9: Climatic tests for Powered Wheelchairs >
• ISO 7176-10:2008, Wheelchairs Part 10: Determination of obstacle-climbing ability of > electrically powered wheelchairs
• ア ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies.

• ISO 7176-13, First edition 1989-08-01, 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 wheelchairs - Requirements and test methods

• ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling

• ISO 16840-10:2021 Wheelchair seating Part 10: Resistance to ignition of postural support devicesRequirements and test method.

• ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers

• ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered wheelchairs >

• IEC 62133-2: 2017: Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

Clinical Test Conclusion ت

No clinical study is included in this submission.

Comparison with predicate Device H.

Compared to the predicate devices, the subject device has the same intended use, similar product design, similar performance, same safety as the predicate device, the summarized comparison information is listed in the following table

| Elements of Comparison | Subject Device | Predicate Device
(K230964) | Remark |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Kunshan Hi-Fortune
Health Products Co.,
Ltd | Zhejiang Innuovo
Rehabilitation Devices
Co.,Ltd | -- |
| Common or Usual name | Electrically powered
wheelchair | Power Wheelchair | -- |
| Model(s) | HP202 | N5909 | -- |
| Classification | Class II | Class II | Same |
| Classification regulation | 21 CFR890.3860 | 21 CFR890.3860 | Same |
| Product code | ITI | ITI | Same |
| | | | |
| Indications for use | It is a motor driven,
indoor and outdoor
transportation vehicle
with the intended use to
provide mobility to a
disabled or elderly
person limited to a
seated position. | It is a motor driven,
indoor and
outdoor
transportation
vehicle
with the intended use to
provide mobility to a
disabled or elderly
person limited to
a
seated position. | S.E. |
| Use condition | indoor and outdoor use | indoor and outdoor use | S.E |
| Number of wheels | 4,including two front
wheels and two rear
Wheels | 4,including two front
wheels and two rear
Wheels | S.E |
| Function of wheels | Front wheels:driven
wheels suitable for
rotation, acceleration,
retrograde Rear wheels:
driving wheels to
control the speed and
direction | Front wheels:driven
wheels
suitable for
rotation,
acceleration,
retrograde Rear wheels:
driving
wheels
to
control the speed and
direction | S.E |
| Movement control
method | By Joystick control | By Joystick control | S.E |
| Driving system | Direct drive on the rear
wheels | Direct drive on the rear
wheels | S.E |
| Brake system | Automatic
electromagnetic
brake system | Automatic
electromagnetic
brake system | S.E |
| Main frame material | Carbon fiber material | Carbon fiber material | S.E |
| Folding method | Collapsible cross-brace | Collapsible cross-brace | S.E |
| Braking distance | ≤1 m | ≤ 1.5 m | Minor difference on
braking distance will
not cause different
performance. Shorter
distance for braking
will be more safety. |
| Maximum
safe
operational incline
degree | 10° | 9 ° | Minor difference on
safe operational
incline degree will
not cause new safety
and effectiveness
concerns, as both the
static and dynamic
stability under
specific inclining
degree have been
evaluated according
to standard ISO 7176
series. |
| Armrest | Carbon fiber material | T700 | Different material
used for parts in |
| | | | |
| Back cushion | comfomesh | Polyester fabric | contact with user,
which such
differences will not |
| Seat cushion | comfomesh | rubber patch cloth and
Oxford fabric | impact the safety and
effectiveness of the
subject device as
biocompatibility tests
are carried out
according to ISO
10993 series. |
| Overall Dimension
(lengthwidthheight) | 1000580900mm | 940610960mm | Minor difference on
wheelchair dimension
will not cause |
| Folded Dimension
(lengthwidthheight) | 870280765mm | 720310610mm | different
performance. All
safety and
performance have
been validated with
the maximum rated
weight dummy.
Analysis |
| Front wheel size/type | 7" PU Solid tire | 7" x 1.75"/PU Solid tire | S.E |
| Rear wheel size/type | 10" PU Solid tire | 8.5"x 2"/ PU Solid tire | Minor difference on
dimension of wheels
will not cause
different
performance. |
| Max speed forward | 6 km/h (1.6 m/s) | Up to 6 km/h (1.6 m/s),
adjustable | S.E |
| Max Speed backward | 0.7 m/s (2.556 km/h) | 0.71 m/s (2.556 km/h) | S.E |
| Max loading weight | 120kg (≈265lbs) | 110kg (≈250lbs) | Difference on loading
weight will not cause
different
performance. All
safety and
performance have
been validated with
the maximum loading
weight. |
| Battery | Li-ion battery pack;
rechargeable, 24 VDC
10Ah | Li-ion battery pack;
rechargeable, 24 VDC
10Ah | S.E |
| Battery charger | Off-board charger
Input: 100-240V,
50/60Hz, 1.5A,
Output: 24 Vdc, 2A; | Off-board charger
Input:100-240V,
50/60Hz, 1.5A,
Output: 24 Vdc, 2A; | S.E |
| Maximum distance of
travel on the fully charged
battery | 11.8km | 10 km | It is caused by the
size of the wheel, will
not cause different
performance, The |
| | | | further away the
better. |
| Motor | Brushless Eco-Drive,
24V,150W, 2pcs | Brushless DC motor;
24VDC; 150W; 2pcs | S.E |
| Electronic controller | Brushless dual-drive
rocker controller | Brushless dual-drive
rocker controller | S.E |
| Turning Radius | 1000mm | 900 mm | Minor difference in
turning radius is
caused by different
size of wheelchair
and may |
| Maximum obstacle
climbing | 20 mm | 40 mm | Minor difference on
obstacle climbing will
not cause new safety
and effectiveness
concerns. |

Table 1 General Comparison

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Substantially Equivalence Discussion:

The proposed device and predicate device are complying to the same ISO standards, ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-7, ISO 7176-7, ISO 7176-8, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 16840-10, ISO 7176-21, ISO 7176-25, and FDA guidance Submission for Power Wheelchair.

The indications for use for both devices are the same. Mainframes of two devices are 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. 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. Turning radius, Maximum obstacle climbing and Maximum safe operational incline are slightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-2 and ISO 7176-10. The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2021 & ISO 10993-23: 2021.

The flame-retardant test of the seat cushion/ backrest of both subject device and predicate device is carried out according to the ISO 16840-10 test. 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.

Item	Proposed Device	Predicate Devices	Results
Biocompatibility	All user directly contacting
materials are compliance with	All user directly contacting
materials are compliance with	S.E.

Table 2 Safety comparison

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| | ISO10993-5, ISO10993-10 and
ISO 10993-23 requirements. | ISO10993-5, ISO10993-10 and
ISO 10993-23 requirements. | |
|-------------|-----------------------------------------------------------|-----------------------------------------------------------|------|
| EMC | ISO7176-21 & IEC 60601-2-1 | ISO7176-21 | S.E. |
| Performance | ISO7176 series | ISO7176 series | S.E. |
| Labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. |

Table 3 Safety comparison

| Item | Proposed Device | Predicate Devices | Resu
lts |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| ISO7176-1 | The Static stability has been determined
after the testing according to the ISO
7176-1, and test results meet its design
specification. | The Static stability has been determined
after the testing according to the ISO
7176-1, and test results meet its design
specification. | S.E. |
| ISO7176-2 | The dynamic stability has been
determined after the testing according to
the ISO 7176-2, and test results meet its
design specification. | The dynamic stability has been
determined after the testing according to
the ISO 7176-2, and test results meet its
design specification. | S.E. |
| ISO7176-3 | The effectiveness of brakes has been
determined after the testing according to
the ISO 7176-3, and test results meet its
design specification. | The effectiveness of brakes has been
determined after the testing according to
the ISO 7176-3, and test results meet its
design specification. | S.E. |
| ISO7176-4 | The theoretical distance range has been
determined after the testing according
to the ISO 7176-4, and test results meet
its design specification. | The theoretical distance range has been
determined after the testing according
to the ISO 7176-4, and test results meet
its design specification. | S.E. |
| ISO7176-5 | The dimensions, mass has been
determined after the testing according to
the ISO 7176-5 | The dimensions, mass has been
determined after the testing according to
the ISO 7176-5 | S.E. |
| ISO7176-6 | The dimensions, mass has been
determined after the testing according to
the ISO 7176-6 | The dimensions, mass has been
determined after the testing according to
the ISO 7176-6 | S.E. |
| ISO7176-7 | The seating and wheel dimensions has
been determined after the testing
according to the ISO 7176-7 | The seating and wheel dimensions has
been determined after the testing
according to the ISO 7176-7 | S.E. |
| ISO7176-8 | All test results meet the
requirements in Clause 4 of ISO
7176-8 | All test results meet the
requirements in Clause 4 of ISO
7176-8 | S.E. |
| ISO7176-9 | The test results shown that the device
under tests could continue to function
according to manufacturer's
specification after being subjected to
each of the tests specified in Clause 8
of ISO 7176-9 | The test results shown that the device
under tests could continue to function
according to manufacturer's
specification after being subjected to
each of the tests specified in Clause 8
of ISO 7176-9 | S.E. |
| ISO7176-10 | The obstacle-climbing ability of
device has been determined after the
testing according to the ISO 7176-10 | The obstacle-climbing ability of
device has been determined after the
testing according to the ISO 7176-10 | S.E. |
| ISO7176-11 | The test dummies used in the testing of
ISO 7176 series are meet the
requirements of ISO 7176-11 | The test dummies used in the testing of
ISO 7176 series are meet the
requirements of ISO 7176-11 | S.E. |
| ISO7176-13 | The coefficient of friction of test surfaces
has been determined, which could be
used in other 7176 series tests involved | The coefficient of friction of test surfaces
has been determined, which could be
used in other 7176 series tests involved | S.E. |
| ISO7176-14 | All test results meet the requirements
in Clause 7, 8, 9, 10, 11, 12, 13, 14,
15, 17 of ISO 7176-14 | All test results meet the requirements
in Clause 7, 8, 9, 10, 11, 12, 13, 14,
15, 17 of ISO 7176-14 | S.E. |
| ISO7176-15 | The test results shown that
information disclosure, documentation
and labelling of device meet the
requirements of ISO 7176-15 | The test results shown that
information disclosure, documentation
and labelling of device meet the
requirements of ISO 7176-15 | S.E. |
| ISO7176-16/
ISO 16840-
10 | The performance of resistance to
ignition meet the requirements of
ISO 16840-10 | The performance of resistance to
ignition meet the requirements of
ISO 16840-10 | S.E. |
| ISO 7176-21 | The EMC performance results meet the
requirements of ISO 7176-21 | The EMC performance results meet the
requirements of ISO 7176-21 | S.E. |
| ISO7176-25 | The performance of batteries and charger
of device meet the Requirements in
Clause 5 and 6 of ISO 7176-25 | The performance of batteries and charger
of device meet the Requirements in
Clause 5 and 6 of ISO 7176-25 | S.E. |

11

I. Conclusion

The conclusion 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 K230964.