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 Electric Wheelchairs, modes!: MP201C, 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, seatbelt, pedal, battery box and charger.

The device is powered by Li-ion Battery pack with 24 Km range, which can be recharged by an offboard 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

This document details the 510(k) premarket notification for an Electric Wheelchair (models MP201C, MP201L), asserting its substantial equivalence to a predicate device (K220747). The acceptance criteria and the study proving the device meets these criteria are primarily based on non-clinical testing against a series of ISO 7176, ISO 10993, and IEC 60601 standards.

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

The acceptance criteria are established by the adherence to various international standards for wheelchairs and medical devices. The reported device performance is indicated by the statement that the test results "meet its design specification" or "comply with the following standards."

Acceptance Criteria (Standard & Requirement)	Reported Device Performance
Biocompatibility
ISO 10993-5:2009 (Cytotoxicity)	Compliance met
ISO 10993-10:2021 (Irritation & Skin Sens.)	Compliance met
ISO 10993-23:2021 (Irritation)	Compliance met
Electromagnetic Compatibility (EMC)
ISO 7176-21:2009 (EMC)	Compliance met (EMC performance results meet requirements)
IEC 60601-2-1 (EMC)	Compliance met (EMC performance results meet requirements)
Performance - ISO 7176 Series Standards
ISO 7176-1:2014 (Static stability)	Determined and met design specification
ISO 7176-2:2017 (Dynamic stability)	Determined and met design specification
ISO 7176-3:2012 (Effectiveness of brakes)	Determined and met design specification
ISO 7176-4:2008 (Energy consumption & theoretical distance range)	Determined and met design specification
ISO 7176-5:2008 (Overall dimensions, mass & maneuvering space)	Determined
ISO 7176-6:2018 (Max speed, acceleration & deceleration)	Determined
ISO 7176-7 (Seating and wheel dimensions)	Determined
ISO 7176-8:2014 (Static, impact & fatigue strengths)	All test results meet Clause 4 requirements
ISO 7176-9:2009 (Climatic tests)	Functions according to manufacturer's specifications after tests
ISO 7176-10:2008 (Obstacle-climbing ability)	Determined
ISO 7176-11:2012 (Test dummies)	Test dummies met requirements
ISO 7176-13:1989 (Coefficient of friction of test surfaces)	Determined
ISO 7176-14:2008 (Power and control systems)	All test results meet Clauses 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 requirements
ISO 7176-15:1996 (Information disclosure, documentation & labeling)	Information disclosure, documentation, and labeling meet requirements
ISO 16840-10:2021 (Resistance to ignition of postural support devices)	Performance meets requirements
ISO 7176-19:2022 (Wheelchairs for use as seats in motor vehicles)	Compliance met
ISO 7176-25:2022 (Lead-acid batteries and chargers)	Compliance met
Braking distance	$\leq$ 1.5 m (reported performance vs predicate)
Maximum safe operational incline degree	10° (reported performance vs predicate)
Maximum distance of travel on fully charged battery	24 km (reported performance vs predicate)
Max loading weight	120 kg (reported performance vs predicate)
Maximum obstacle climbing	25mm (reported performance vs predicate)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size for non-clinical tests. It refers to various ISO and IEC standards, implying that the test samples and methods prescribed by these standards were followed. The provenance of the data is not specified in terms of country of origin but is implicitly derived from tests conducted by the manufacturer, Suzhou Master Machinery Manufacturing Co., Ltd. (China). The tests outlined are non-clinical, likely prospective in nature as they involve testing the physical device against performance standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The ground truth for performance is established by the defined parameters and methodologies within the cited ISO and IEC standards, which are internationally recognized. The compliance of the device with these standards is verified through testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to non-clinical device performance testing against established standards. The tests are designed to objectively measure specific parameters.

5. 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

No such study was conducted, as this is a physical medical device (electric wheelchair) and not an AI-assisted diagnostic or interpretative tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. The device is an electric wheelchair, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical tests is based on pre-defined specifications and international performance standards (ISO, IEC). These standards establish objective metrics and test methods for evaluating the safety and effectiveness of wheelchairs. For example, for "Braking distance $\leq$ 1.5 m," the ground truth is the specified maximum allowed distance according to relevant standards.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this device.

Summary

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

July 18, 2024

Suzhou Master Machinery Manufacturing Co.,Ltd % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, Shanghai 200122 China

Re: K241463

Trade/Device Name: Electric Wheelchair (MP201C): Electric Wheelchair (MP201L) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: May 23, 2024 Received: May 23, 2024

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 (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.

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

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

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

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

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

Sincerely,

Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team

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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 Healt

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Indications for Use

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

Submission Number (if known)

K241463

Device Name

Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

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510(K) Summary

Document Prepared Date: 2024/5/21

Applicant: A. Suzhou Master Machinery Manufacturing Co.,Ltd. Address: 2F, Block B, No. 379, Delan Industrial Park, Zhangpu Town, Kunshan, Jiangsu,China Contact Person: Hongying Wu Tel: +86- 15190195122

Submission Correspondent: Primary contact: Mr. Jarvis Wu Title: Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: jiawei.wu@sungoglobal.com

Secondary contact: Mr. Raymond Luo Title: Technical Director Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com

B. Device:

Trade Name: Electric Wheelchair Common Name: Powered wheelchair Model: MP201C, MP201L

Regulatory Information 510K Number: K241463 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:

510Knumber: K220747 Classification Name: Electric Wheelchair Regulation Number: 890.3860 Device Name: Power Wheelchair Model: N5515B 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 device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, 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 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 A
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
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 7176-19:2022 Wheelchairs Part 19: Wheelchairs for use as seats in motor vehicles >
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers
ISO 7176-25:2022 Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs Requirements and test methods

G. Clinical Test Conclusion

No clinical study is included in this submission.

H. Comparison with predicate Device

		Table 1 General Comparison
--	--	----------------------------

Elements of Comparison	Subject Device	Predicate Device (K220747)	Remark
Manufacturer	Suzhou Master Machinery	Zhejiang Innuovo	-
	Manufacturing Co.,Ltd.	Rehabilitation Devices Co.,Ltd
Common or Usual name	Power Wheelchair	Power Wheelchair	Same
Model(s)	MP201C, MP201L	N5515B	--
Indications for use	It is a motor driven, indoor andoutdoor transportation vehiclewith the intended use toprovide mobility to a disabledor elderly person limited to aseated position.	It is a motor driven, indoor andoutdoor transportation vehiclewith the intended use toprovide mobility to a disabledor elderly person limited to aseated position.	S.E.
Use condition	indoor and outdoor use	indoor and outdoor use	S.E
Number of wheels
	4,including two front wheelsand two rear Wheels	4,including two front wheelsand two rear Wheels	S.E
Function of wheels	Front wheels:driven wheelssuitable for rotation,acceleration, retrograde.Rear wheels: driving wheels tocontrol the speed and direction	Front wheels:driven wheelssuitable for rotation,acceleration, retrograde.Rear wheels: driving wheels tocontrol the speed and direction	S.E
Movement controlmethod	By Joystick control	By Joystick control	S.E
Driving system	Direct drive on the rearwheels	Direct drive on the rear wheels	S.E
Brake system	Automatic electromagneticbrake system	Automatic electromagneticbrake system	S.E
Braking distance	$\leq$ 1.5 m	$\leq$ 1.5 m	S.E
Maximum safeoperational incline degree	10°	9 °	Analysis
Armrest	MP201C Model:Carbon fiber materialMP201L Model: PU	PU	Analysis
Battery charger	Off-board chargerInput: 100-240V, 50/60Hz, 1.9-0.5A,Output: 24 Vdc, 4A;	Off-board chargerInput: 100-240V, 50/60Hz, 1.5AOutput: 24 Vdc, 2A;	S.E
Main frame material	MP201C Model:Carbon fiber materialMP201L Model:Aluminum Alloy	Carbon fiber material	Analysis
Back cushion	Polyester fabric	Polyester fabric	S.E
Seat cushion	Polyester fabric	rubber patch cloth and Oxfordfabric	Analysis
Overall Dimension(lengthwidthheight)	1020640900mm	940610960mm	S.E
Folded Dimension(lengthwidthheight)	750640340mm	720310610mm	S.E
Front wheel size/type	7" x 1.5" /PU Solid tire	7" x 1.75"/PU Solid tire	S.E
Rear wheel size/type	10"x1.8" /PU solid tires	8.5"x 2"/ PU Solid tire	Analysis
Max speed forward	Up to 6 km/h (1.6 m/s),adjustable	Up to 6 km/h (1.6m/s),adjustable	S.E
Max Speed backward	Less than 3 km/h (0.8m/s)	Less than 3 km/h (0.8m/s)	S.E
Max loading weight	120kg	136 kg	Analysis
Battery	Li-ion battery pack;rechargeable, 25.2 VDC 20Ah	Li-ion battery pack;rechargeable, 24 VDC 12Ah	Analysis
Maximum distance oftravel on the fully chargedbattery	24 km	15 km	Analysis
Motor	Brushless DC motor; 24VDC;170W; 2pcs	Brushless DC motor; 24VDC;250W; 2pcs	Analysis
Electronic controller	Brushless dual-drive rockercontroller	Brushless dual-drive rockercontroller	S.E
Turning radius	940 mm	900 mm	Analysis
Maximum obstacleclimbing	25 mm	40 mm	Analysis

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Difference analysis:

The design and technological characteristics of the Electric Wheelchair is similar to the predicates chosen. There are minor differences between the devices including Maximum safe operational incline degree, Main frame material, Armrest, Seat & Back cushion, Battery charger, Rear wheel size, Max loading weight, Battery,Maximum distance of travel on the fully charged battery, Turning Radius and Maximum obstacle climbing. All of the parameter with difference have been tested according to ISO 7176 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 (K220747).

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.

Table 2 Safety comparison
---------------------------	--

Item	Proposed Device	Predicate Devices	Results
Biocompatibility	All user directly contactingmaterials are compliance withISO10993-5, ISO10993-10 andISO 10993-23 requirements.	All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements.	S.E.
EMC	ISO7176-21 & IEC 60601-2-1	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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I. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Electric Wheelchair, models: MP201C, MP201, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K220747.

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 been determinedafter the testing according to the ISO7176-1, and test results meet its designspecification.	The Static stability has been determinedafter the testing according to the ISO7176-1, and test results meet its designspecification.	S.E.
ISO7176-2	The dynamic stability has beendetermined after the testing according tothe ISO 7176-2, and test results meet itsdesign specification.	The dynamic stability has beendetermined after the testing according tothe ISO 7176-2, and test results meet itsdesign specification.	S.E.
ISO7176-3	The effectiveness of brakes has beendetermined after the testing according tothe ISO 7176-3, and test results meet itsdesign specification.	The effectiveness of brakes has beendetermined after the testing according tothe ISO 7176-3, and test results meet itsdesign specification.	S.E.
ISO7176-4	The theoretical distance range has beendetermined after the testing accordingto the ISO 7176-4, and test results meetits design specification.	The theoretical distance range has beendetermined after the testing accordingto the ISO 7176-4, and test results meetits design specification.	S.E.
ISO7176-5	The dimensions, mass has beendetermined after the testing according tothe ISO 7176-5	The dimensions, mass has beendetermined after the testing according tothe ISO 7176-5	S.E.
ISO7176-6	The dimensions, mass has beendetermined after the testing according tothe ISO 7176-6	The dimensions, mass has beendetermined after the testing according tothe ISO 7176-6	S.E.
ISO7176-7	The seating and wheel dimensions hasbeen determined after the testingaccording to the ISO 7176-7	The seating and wheel dimensions hasbeen determined after the testingaccording to the ISO 7176-7	S.E.
ISO7176-8	All test results meet therequirements in Clause 4 of ISO7176-8	All test results meet therequirements in Clause 4 of ISO7176-8	S.E.
ISO7176-9	The test results shown that the deviceunder tests could continue to functionaccording to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9	The test results shown that the deviceunder tests could continue to functionaccording to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9	S.E.
ISO7176-10	The obstacle-climbing ability ofdevice has been determined after thetesting according to the ISO 7176-10	The obstacle-climbing ability ofdevice has been determined after thetesting according to the ISO 7176-10	S.E.
ISO7176-11	The test dummies used in the testing ofISO 7176 series are meet therequirements of ISO 7176-11	The test dummies used in the testing ofISO 7176 series are meet therequirements of ISO 7176-11	S.E.
ISO7176-13	The coefficient of friction of test surfaceshas been determined, which could beused in other 7176 series tests involved	The coefficient of friction of test surfaceshas been determined, which could beused in other 7176 series tests involved	S.E.
ISO7176-14	All test results meet the requirementsin Clause 7, 8, 9, 10, 11, 12, 13, 14,15, 17 of ISO 7176-14	All test results meet the requirementsin Clause 7, 8, 9, 10, 11, 12, 13, 14,15, 17 of ISO 7176-14	S.E.
ISO7176-15	The test results shown thatinformation disclosure, documentationand labelling of device meet therequirements of ISO 7176-15	The test results shown thatinformation disclosure, documentationand labelling of device meet therequirements of ISO 7176-15	S.E.
ISO7176-16/ISO 16840-10	The performance of resistance toignition meet the requirements ofISO 16840-10	The performance of resistance toignition meet the requirements ofISO 7176-16	S.E.
ISO 7176-21	The EMC performance results meet therequirements of ISO 7176-21	The EMC performance results meet therequirements of ISO 7176-21	S.E.