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.

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

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.

AI/ML Overview

The provided document is a 510(k) summary for an Electrically Powered Wheelchair (Models: YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel AI/ML algorithm or its associated performance study.

Therefore, the document does not contain the information requested in questions 2 through 9 regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is typically found in submissions for AI/ML-powered devices, which require specific clinical performance studies to validate their effectiveness.

However, I can extract information related to acceptance criteria (safety and performance standards) and the "study" that proves the device meets them, which in this case, refers to non-clinical testing against recognized performance standards.

Here's the relevant information from the document:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this device are primarily adherence to a comprehensive set of ISO 7176 series standards for wheelchairs, along with biocompatibility standards (ISO 10993) and electromagnetic compatibility (EMC) standards. The "reported device performance" is essentially a statement of compliance with these standards.

Acceptance Criteria (Standard)	Reported Device Performance
Biocompatibility
ISO 10993-5: 2009 (In Vitro Cytotoxicity)	All user directly contacting materials are compliant with ISO 10993-5.
ISO 10993-10: 2010 (Irritation And A Skin Sensitization)	All user directly contacting materials are compliant with ISO 10993-10.
Functional & Performance Standards (ISO 7176 Series)
ISO 7176-1: 2014 (Static stability)	Test results meet design specification.
ISO 7176-2: 2017 (Dynamic stability of Powered Wheelchairs)	Test results meet design specification.
ISO 7176-3: 2012 (Effectiveness of brakes)	Test results meet design specification.
ISO 7176-4: 2008 (Energy consumption & theoretical distance range)	Test results meet design specification.
ISO 7176-5: 2008 (Overall dimensions, mass and manoeuvring space)	Dimensions and mass determined.
ISO 7176-6: 2018 (Maximum speed, acceleration and deceleration)	Maximum speed, acceleration, and deceleration determined.
ISO 7176-7 (Measurement of seating and wheel dimensions)	Seating and wheel dimensions determined.
ISO 7176-8: 2014 (Static, impact and fatigue strengths)	All test results meet requirements in Clause 4 of ISO 7176-8.
ISO 7176-9: 2009 (Climatic tests for Powered Wheelchairs)	Device continues to function according to manufacturer's specification.
ISO 7176-10: 2008 (Obstacle-climbing ability)	Obstacle-climbing ability determined.
ISO 7176-11: 2012 (Test dummies)	Test dummies used meet requirements of ISO 7176-11.
ISO 7176-13: 1989 (Coefficient of friction of test surfaces)	Coefficient of friction determined for use in other 7176 series tests.
ISO 7176-14: 2008 (Power and control systems)	All test results meet requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14.
ISO 7176-15: 1996 (Information disclosure, documentation and labeling)	Information disclosure, documentation, and labeling meet requirements.
ISO 7176-16: 2012 (Resistance to ignition of postural support devices)	Performance of resistance to ignition meet requirements.
ISO 7176-21: 2009 (EMC of electrically powered wheelchairs)	EMC performance results meet requirements.
ISO 7176-25: 2013 (Batteries and chargers for powered wheelchairs)	Performance of batteries and charger meet requirements in Clause 5 and 6.
Other
Label and labeling (FDA Regulatory)	Conforms to FDA Regulatory.

The Study that Proves the Device Meets Acceptance Criteria:

The "study" to demonstrate that the Electrically Powered Wheelchairs meet the acceptance criteria is described as non-clinical tests conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device.

Specifically, the document states: "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."

The specific standards listed above (ISO 10993 series, ISO 7176 series, and ISO 7176-21) constitute the framework for these non-clinical tests. These tests assess various aspects of the wheelchair's safety and performance, such as stability, braking, speed, obstacle climbing, material biocompatibility, and electromagnetic compatibility.

The following questions (2-9) are not applicable to this 510(k) submission as it focuses on substantial equivalence of a physical medical device (powered wheelchair) through non-clinical testing against recognized standards, rather than the performance of an AI/ML algorithm or a clinical study.

Sample size used for the test set and the data provenance: Not applicable. This submission relies on non-clinical engineering tests performed on the physical device, not on a dataset or test set in the context of AI/ML.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, is not relevant to the non-clinical testing of a physical medical device against performance standards. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified ISO standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept applies to expert review and consensus for ground truth establishment in AI/ML performance studies, which is not present here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a traditional medical device (powered wheelchair), not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm being evaluated in this submission.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a powered wheelchair's performance is objective compliance with engineering and safety standards, as measured by standard test procedures, not clinical outcomes or expert labels.
The sample size for the training set: Not applicable. There is no AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable. There is no AI/ML algorithm that requires a training set.

Summary

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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.

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

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

For comprehensive regulatory information about 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

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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:

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

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

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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 ofComparison	Subject Device(K232193)	Predicate Device(K113463)	Remark
Manufacturer	Yurob RehabilitationMedical Co.,Ltd.	SUZHOU KDMedicalAppliance Co. Ltd.
Common or Usualname	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, indoorand outdoor transportationvehicle with the intendeduse to provide mobility toa disabled or elderlyperson limited to a seatedposition.	It is a motor driven,indoorandoutdoortransportationvehiclewith the intended use toprovide mobility toadisabledorelderlyperson limited to a seatedposition.	S.E.
Use condition	indoor and outdoor use	indoor and outdoor use	S.E
Number of wheels	4,including two frontwheels and two rearWheels	4,includingtwofrontwheels andtworearWheels	S.E
Function of wheels	Front wheels:drivenwheels suitable forrotation, acceleration,retrograde Rear wheels:driving wheels to controlthe speed and direction	Front wheels:drivenwheelssuitable forrotation,acceleration,retrograde Rear wheels:driving wheels to controlthe speed and direction	S.E
Movement controlmethod	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 chargerInput: 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:1000660900mmYLB-W-0812-A02 Model:920550890mmYLB-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:660350800mmYLB-W-0812-A02 Model:660320720mm	720570400mm	Analysis:Difference on folded dimension will not affect safety and
	YLB-W-0812-A03 Model:810330700mm		perfonnance of thesubject device.
Front wheel size/type	YLB-W-0812-A01 Model:8" PU Solid tireYLB-W-0812-A02 Model:7" PU Solid tireYLB-W-0812-A03 Model:8" PU Solid tire	6" x 2"/PU Solid tire	Analysis:Different sizes of frontwheel will not affectsafety and perfonnanceof the subject device asallrelated stability tests areperformed according tostandard ISO 7176series.
Rear wheel size/type	YLB-W-0812-A01 Model:12" PU Solid tireYLB-W-0812-A02 Model:12" Pneumatic tireYLB-W-0812-A03 Model:12" Pneumatic tire	8"x 2.4"/ PU Solid tire	Analysis:Different sizes andmaterials of rear wheelwill not affect the safetyand perfonnance of thesubject device as allrelated stability tests areperfonned according tostandard ISO 7176series.
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 maxbackward speed will bemore safety.
Max loading weight	120 Kg (≈654 lbs)	114 kg (≈251 lbs)	S.E
Battery	Li-ion batteryrechargeable, 25.2VDC10.4Ah *2	Li-ion, Rechargeable; 24VDC 20Ah	Analysis:The battery capacitywill impact the traveldistance, which will notcause new safety andeffectiveness concernsraised.
Maximum distance oftravel on the fullycharged battery	20km	20 km	S.E
Motor	Brushless DC motor;24VDC; 150W, 2pcs	Brushless DC motor;24VDC; 180W; 2pcs	Analysis:Slight difference onmotor power will notcause differentperformance. largerpower will providemore driving force, nosafety and effectivenessconcerns raised.
Electronic controller	Brushless dual-driverocker controller	Brushless dual-driverocker controller	S.E
Turning Radius			Analysis:
	900 mm	31.5" (800 mm)	Larger turning radiuswill bring moreconvenience for the useenvironment. Allrelevant tests have beenperformed according tostandards ISO 7176series, the differencewill not raise any newsafety and effectivenessconcerns.
Maximum obstacleclimbing	40 mm	1.2" (30 mm)	Analysis:Longer distance in theobstacle climbing willnot impact the safetyand effectiveness of thesubject device.

Table 1 General Comparison

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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 contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements.	All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 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
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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.

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).

Item	Proposed Device	Predicate Devices	Results
ISO7176-1	The Static stability has beendetermined after the testing accordingto the ISO 7176-1, and test resultsmeet its design specification.	The Static stability has beendetermined after the testing accordingto the ISO 7176-1, and test results meetits design specification.	S.E.
ISO7176-2	The dynamic stability has beendetermined after the testing accordingto the ISO 7176-2, and test results	The dynamic stability has beendetermined after the testing accordingto the ISO 7176-2, and test results meetits 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 thatinformation disclosure,documentation and labelling ofdevice meet the requirements ofISO 7176-15	The test results shown thatinformation disclosure,documentation and labelling ofdevice meet the requirements of ISO7176-15	S.E.


ISO7176-16		The performance of resistance toignition meet the requirements ofISO 7176-16	The performance of resistance toignition meet the requirements ofISO 7176-16	S.E.
ISO 7176-21		The EMC performance results meetthe requirements of ISO 7176-21	The EMC performance results meet therequirements of ISO 7176-21	S.E.
ISO7176-25		The performance of batteries andcharger of device meet theRequirements in Clause 5 and 6 ofISO 7176-25	The performance of batteries andcharger of device meet theRequirements in Clause 5 and 6 of ISO7176-25	S.E.