Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard power wheelchair with a joystick control and electromagnetic brake. There is no mention of adaptive learning, predictive capabilities, or any other features typically associated with AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No.
The device is described as a transportation vehicle to provide mobility, not to treat or diagnose a medical condition.

Diagnostic

No

The description clearly states the device is a "Power wheelchair" intended to provide "mobility to a disabled or elderly person". It is a transportation vehicle, not something that diagnoses medical conditions.

SaMD (Software as a Medical Device)

No

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

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The description clearly states that this device is a power wheelchair used for mobility and transportation for disabled or elderly individuals. It assists with movement, not with analyzing biological samples.
Intended Use: The intended use is to provide mobility, not to diagnose, monitor, or treat a medical condition through the analysis of in vitro samples.
Device Components: The components listed (wheels, frame, motor, battery, controller, etc.) are all related to a mechanical transportation device, not laboratory testing equipment.
Performance Studies: The performance studies mentioned are related to the physical and electrical safety and functionality of a wheelchair, not the accuracy or reliability of diagnostic tests.

The information provided strongly indicates that this device is a mobility aid, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Power wheelchair 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 is a motor driven, indoor and outdoor 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.

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

The device is powered by Li-ion Battery pack (25.2V 10.4Ah*2) with 20 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 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

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 Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And A Skin Sensitization
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
A 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 >
ア 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
ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies.
ISO 7176-13, First edition 1989-08-01, Wheelchairs Part 13: Determination of coefficient A 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 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices.
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

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

Not Found

Predicate Device(s)

K113463

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 contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

September 22, 2023

Yurob Rehabilitation Medical Co.,Ltd. % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Century Ave., Shanghai 200122, China Shanghai, Shanghai 200122 China

Re: K232193

Trade/Device Name: Electrically Power Wheelchairs (Models: YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: July 25, 2023 Received: July 25, 2023

Dear Jarvis Wu:

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

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

1

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

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

For comprehensive regulatory information about 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.

Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known) K232193

Device Name Power wheelchair (YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)

Indications for Use (Describe)

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

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510(K) Summary

Document Prepared Date: 2023/7/21

A. Applicant: Yurob Rehabilitation Medical Co.,Ltd. Address: No.93 Dianxing Road, Dianshanhu Town, Kunshan City, Jiangsu Province, China Contact Person: Pan daoping Tel: +86 13918374973

Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: zxfda(@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com

B. Device:

Trade Name: Electrically Power Wheelchairs Common Name: Powered wheelchair Models: YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03

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

C. Predicate device:

510Knumber: K113463 Device Name: Power Wheelchair Model: PL001 SUZHOU KD Medical Appliance Co. Ltd.

D. Indications for use of the device:

4

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:

This Power wheelchair is a motor driven, indoor and outdoor 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.

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

The device is powered by Li-ion Battery pack (25.2V 10.4Ah*2) with 20 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 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.

F. Non-Clinical Test Conclusion

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 Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And A Skin Sensitization
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
A 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 >
ア 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

5

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, First edition 1989-08-01, Wheelchairs Part 13: Determination of coefficient A 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 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices.
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

G. Clinical Test Conclusion

No clinical study is included in this submission.

H. Comparison with predicate Device

| Elements of
Comparison | Subject Device
(K232193) | Predicate Device
(K113463) | Remark |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Yurob Rehabilitation
Medical Co.,Ltd. | SUZHOU KDMedical
Appliance Co. Ltd. | |
| Common or Usual
name | Power Wheelchair | Power Wheelchair | S.E. |
| Model(s) | YLB-W-0812-A01,
YLB-W-0812-A02,
YLB-W-0812-A03 | PL001 | -- |
| 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 | Intelligent regenerative Electromagnetic brake | S.E |
| Braking distance | $ \le 1.5 m $ | Forward: 1.5m (59") at max speed | S.E |
| Maximum safe operational incline degree | 6° | 9° | Analysis:
Minor difference on safe operational incline degree will not cause new safety and effectiveness concerns are raised as both the static and dynamic stability under specific inclining degree have been evaluated according to standard ISO 7176 series. |
| Armrest | PU | PU | S.E |
| Battery charger | Off-board charger
Input: 100-240V, 50/60Hz,
Output: 24Vdc 2A | Off-board, Automatic Type Input: 110-220 V / 50-60 Hz,
Output: 24 Vdc, 2A; | S.E |
| Main frame material | Aluminum Alloy | Aluminum Alloy | S.E |
| Back cushion | Polyester fabric | PU foam covered by nylon fabric cloth | Analysis:
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. |
| Seat cushion | rubber patch cloth and Oxford fabric | PU foam covered by nylon fabric cloth | |
| Overall Dimension (lengthwidthheight) | YLB-W-0812-A01 Model:
1000660900mm
YLB-W-0812-A02 Model:
920550890mm
YLB-W-0812-A03 Model:
1060645990mm | 880570890mm | Analysis:
Larger size is designed for bearing more loading weight. All safety and performance have been validated with the maximum rated weight dummy. |
| Folded Dimension (lengthwidthheight) | YLB-W-0812-A01 Model:
660350800mm
YLB-W-0812-A02 Model:
660320720mm | 720570400mm | Analysis:
Difference on folded dimension will not affect safety and |
| | YLB-W-0812-A03 Model:
810330700mm | | perfonnance of the
subject device. |
| Front wheel size/type | YLB-W-0812-A01 Model:
8" PU Solid tire
YLB-W-0812-A02 Model:
7" PU Solid tire
YLB-W-0812-A03 Model:
8" PU Solid tire | 6" x 2"/PU Solid tire | Analysis:
Different sizes of front
wheel will not affect
safety and perfonnance
of the subject device as
all
related stability tests are
performed according to
standard ISO 7176
series. |
| Rear wheel size/type | YLB-W-0812-A01 Model:
12" PU Solid tire
YLB-W-0812-A02 Model:
12" Pneumatic tire
YLB-W-0812-A03 Model:
12" Pneumatic tire | 8"x 2.4"/ PU Solid tire | Analysis:
Different sizes and
materials of rear wheel
will not affect the safety
and perfonnance of the
subject device as all
related stability tests are
perfonned according to
standard ISO 7176
series. |
| Max speed forward | Up to 6 km/h | Up to 6 km/h (3.75 mph),
variable | S.E |
| Max Speed backward | Less than 3 km/h (0.8 m/s) | 2.4 mph (3.84 km/h) | Analysis:
Lower speed on max
backward speed will be
more safety. |
| Max loading weight | 120 Kg (≈654 lbs) | 114 kg (≈251 lbs) | S.E |
| Battery | Li-ion battery
rechargeable, 25.2VDC
10.4Ah *2 | Li-ion, Rechargeable; 24
VDC 20Ah | Analysis:
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 | 20km | 20 km | S.E |
| Motor | Brushless DC motor;
24VDC; 150W, 2pcs | Brushless DC motor;
24VDC; 180W; 2pcs | Analysis:
Slight difference on
motor power will not
cause different
performance. larger
power will provide
more driving force, no
safety and effectiveness
concerns raised. |
| Electronic controller | Brushless dual-drive
rocker controller | Brushless dual-drive
rocker controller | S.E |
| Turning Radius | | | Analysis: |
| | 900 mm | 31.5" (800 mm) | Larger turning radius
will bring more
convenience for the use
environment. All
relevant tests have been
performed according to
standards ISO 7176
series, the difference
will not raise any new
safety and effectiveness
concerns. |
| Maximum obstacle
climbing | 40 mm | 1.2" (30 mm) | Analysis:
Longer distance in the
obstacle climbing will
not impact the safety
and effectiveness of the
subject device. |

Table 1 General Comparison

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7

8

I. Difference analysis

The design and technological characteristics of the Power Wheelchair is similar to the predicates chosen. There are minor differences between the devices including Maximum safe operational incline degree, Overall Dimension,Folded Dimension, Rear wheel size/type, Max Speed backward, Turning Radius and Maximum obstacle climbing. All of the parameter with difference have been tested according to ISO7176 series standards and the test records support its safety and effectiveness. There is no deleterious effect on safety and effectiveness due to the minor differences do not influence the intended use of the device. Therefore, the proposed Wheelchair is substantially equivalent (SE) to The Power Wheelchair (K113463).

Table 2 Safety comparison

Item	Proposed Device	Predicate Devices	Results
Biocompatibility	All user directly contacting
materials are compliance with
ISO10993-5 and
ISO10993-10 requirements.	All user directly contacting
materials are compliance with
ISO10993-5 and
ISO10993-10 requirements.	S.E.
EMC	ISO7176-21	ISO7176-21	S.E.
Performance	ISO7176 series	ISO7176 series	S.E.
Label and labeling	Conforms to FDA Regulatory	Conforms to FDA Regulatory	S.E.

		Table 3 Safety comparison
--	--	---------------------------

Item	Proposed Device	Predicate Devices	Results
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	The dynamic stability has been
determined after the testing according
to the ISO 7176-2, and test results meet
its design specification.	S.E.
	meet its design specification.	its design specification.
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 7176-5,	The dimensions, mass has been determined after the testing according to the ISO 7176-5.	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	All test results meet the requirements in Clause 7, 8, 9, 10	S.E.
		11, 12, 13, 14, 15, 17 of ISO 7176-
14	11, 12, 13, 14, 15, 17 of ISO 7176-
14
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		The performance of resistance to
ignition meet the requirements of
ISO 7176-16	The performance of resistance to
ignition meet the requirements of
ISO 7176-16	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.

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J. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Electrically Power Wheelchair, model: YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K113463.