The Power Wheelchair (Model: JMPW-01W) 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.

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 Lead-acid Battery pack (24V 20Ah) with 8 miles range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

AI/ML Overview

The provided document is a 510(k) premarket notification for a power wheelchair (Model: JMPW-01W). It assesses the substantial equivalence of the new device to a legally marketed predicate device (K163204). The document does not describe an AI/ML-driven device or diagnostic study. Instead, it focuses on the engineering and physical performance of a medical device (a power wheelchair) and its compliance with established international standards for such devices.

Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, effect size) are not applicable to this document as it pertains to a physical medical device.

However, I can extract the closest analogous information regarding acceptance criteria and performance based on the provided text, particularly from the "Non-Clinical Test Conclusion" and "Comparison with predicate Device" sections.

Acceptance Criteria and Device Performance for Power Wheelchair (Model: JMPW-01W)

Since this is a physical medical device (power wheelchair) and not an AI/ML diagnostic device, the "acceptance criteria" are primarily based on compliance with international standards (ISO 7176 series for wheelchairs) and demonstrating substantial equivalence to a predicate device. The "performance" is reported as meeting the requirements of these standards.

1. Table of Acceptance Criteria & Reported Device Performance

Feature/Test (Acceptance Criteria Based on Standard)	ISO Standard Reference	Reported Device Performance	Remark/Conclusion (vs. Predicate)
Biocompatibility: User-contacting materials compliance	ISO 10993-5: 2009 (Cytotoxicity) & ISO 10993-10: 2010 (Irritation/Skin Sensitization)	Compliant with ISO 10993-5 and ISO 10993-10 requirements.	Substantially Equivalent (S.E.) - Biocompatibility tests conducted to verify safety/effectiveness of material.
Electromagnetic Compatibility (EMC)	ISO 7176-21: 2009	Performance results meet ISO 7176-21 requirements.	S.E.
Static Stability	ISO 7176-1: 2014	Determined after testing; results meet design specification.	S.E.
Dynamic Stability	ISO 7176-2: 2017	Determined after testing; results meet design specification.	S.E.
Effectiveness of Brakes	ISO 7176-3: 2012	Determined after testing; results meet design specification.	S.E.
Energy Consumption/Theoretical Distance Range	ISO 7176-4: 2008-10-01	Determined after testing; results meet design specification.	S.E. - Differences in travel distance from predicate do not affect safety/effectiveness.
Overall Dimensions, Mass, Maneuvering Space	ISO 7176-5: 2008-06-01	Determined after testing.	S.E. - Minor differences in dimensions will not impact safety/effectiveness.
Max Speed, Acceleration, Deceleration	ISO 7176-6: 2018	Determined after testing; results meet design specification.	S.E. - Slight differences in max speed from predicate do not affect safety/performance, as stability tests are performed per standard.
Seating and Wheel Dimensions	ISO 7176-7	Determined after testing.	S.E.
Static, Impact, Fatigue Strengths	ISO 7176-8: 2014 (Clause 4 requirements)	All test results meet requirements.	S.E.
Climatic Tests (Function after exposure)	ISO 7176-9: 2009 (Clause 8 tests)	Device continues to function according to manufacturer's specifications.	S.E.
Obstacle-Climbing Ability	ISO 7176-10: 2008	Determined after testing.	S.E.
Test Dummies (Used in other tests)	ISO 7176-11: 2012	Test dummies meet requirements.	S.E.
Coefficient of Friction of Test Surfaces	ISO 7176-13: 1989-08-01	Determined for use in other tests.	S.E.
Power and Control Systems	ISO 7176-14: 2008 (Clauses 7-15, 17 requirements)	All test results meet requirements.	S.E.
Information Disclosure, Documentation, Labeling	ISO 7176-15: 1996	Test results show compliance with requirements.	S.E.
Resistance to Ignition of Postural Support Devices	ISO 7176-16: 2012	Performance meets requirements.	S.E.
Batteries and Chargers	ISO 7176-25: 2013 (Clauses 5 & 6 requirements)	Performance meets requirements.	S.E. - Differences in battery type from predicate do not affect safety/effectiveness, as compliance with this standard and EMC testing is shown.
Braking Distance	N/A (Comparative spec)	1 meter	S.E. (Matches predicate)
Maximum Safe Operational Incline Degree	N/A (Comparative spec)	6°	S.E. (Predicate 0-12°, 6° falls within this range)
Max Loading Weight	N/A (Comparative spec)	250 lbs (113.4kg)	S.E. (Predicate 220 lbs (100 kg))

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not applicable in the context of an AI/ML study. For a physical device like a power wheelchair, testing is typically done on a representative sample or a single unit to demonstrate compliance with standards. The document does not specify a "sample size" in the way it would for a clinical trial or AI/ML validation.
Data Provenance: The tests were non-clinical, conducted to verify the device meets design specifications and complies with ISO standards. The country of origin for the testing itself is not explicitly stated, but the applicant (manufacturer) is based in Jiangsu, China. The data is from non-clinical testing, not retrospective or prospective patient data.

3. Number of Experts and Qualifications for Ground Truth:

Not Applicable. Ground truth, in the context of an AI/ML study, refers to the definitive label for data, typically established by human experts. For a physical device, compliance is determined by adherence to engineering standards and test protocols, not expert interpretation of outputs.

4. Adjudication Method:

Not Applicable. Adjudication is a process to resolve disagreements among human experts in establishing ground truth for AI/ML validation data. This concept does not apply to the conformity testing of a physical medical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not Applicable. MRMC studies are specific to evaluating how AI assistance impacts human reader performance in diagnostic tasks. This is a physical device, not an AI diagnostic tool. No human readers or diagnostic tasks are involved in proving the performance of a power wheelchair.

6. Standalone Performance (Algorithm Only without Human-in-the-loop):

Not Applicable. This concept applies to AI algorithms. The device is a power wheelchair, which operates based on mechanical and electrical engineering principles, not an AI algorithm. Its "standalone performance" refers to its intrinsic functional capabilities as demonstrated through the ISO standard tests, not an AI algorithm's output.

7. Type of Ground Truth Used:

Engineering Standards and Test Protocols. For this device, the "ground truth" is established by compliance with the specified international engineering standards (ISO 7176 series, ISO 10993 series) and specific performance metrics (e.g., braking distance, max speed, load capacity). The objective is to demonstrate that the device's measured performance meets the requirements set forth in these standards.

8. Sample Size for Training Set:

Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. (See point 8).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

January 19, 2024

Jiangsu Jumao x-Care Medical Equipment Co., Ltd % Jarvis Wu Senior Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K232783

Trade/Device Name: Power wheelchair (Model: JMPW-01W) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: December 26, 2023 Received: December 26, 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{1}------------------------------------------------

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

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

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

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

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

Sincerely.

Heather L. Dean -S

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

{2}------------------------------------------------

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

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K232783

Device Name Power wheelchair (Model: JMPW-01W)

Indications for Use (Describe)

The Power Wheelchair (Model: JMPW-01W) is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)	[X] Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

{4}------------------------------------------------

510(k) Summary

K232783

Document Prepared Date: 2024/01/09

A. Applicant:

Jiangsu Jumao x-care Medical Equipment Co., Ltd Address: No.36 Danyan Road, Danyang, Jiangsu, China Contact Person: Weixia Shi Tel: +86 16605112488

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: jiawei.wu@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda(@sungoglobal.com

B. Device:

Trade Name: Power wheelchair Common Name: Powered wheelchair Model: JMPW-01W

Regulatory Information Classification Name: Powered wheelchair Classification: Class II Product code: ITI

Regulation Number: 890.3860

Review Panel: Physical Medicine

C. Predicate device:

510k number: K163204 Device Name: Power Wheelchair Model: A08 Kunshan Aoshida Electric Technology Co., Ltd.

{5}------------------------------------------------

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, pedal, battery box and charger.

The device is powered by Lead-acid Battery pack (24V 20Ah) with 8 miles range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

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

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 ハ Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And > Skin Sensitization
ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability ム
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 >
A 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 A dimensions, mass and maneuvering space
ISO 7176-6: 2018, Wheelchairs Part 6: Determination of maximum speed, acceleration A 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 >

{6}------------------------------------------------

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 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.

Elements ofComparison	Subject Device	Predicate Device (K163204)	Remark
Manufacturer	Jiangsu Jumao x-careMedical Equipment Co.,Ltd	Kunshan Aoshida ElectricTechnology Co., Ltd.	-
Common or Usualname	Power Wheelchair	Power Wheelchair	S.E.
Model(s)	JMPW-01W	A08	--
Indications for use	It is a motor driven, indoorand outdoor transportationvehicle with the intended useto provide mobility to adisabled or elderly personlimited to a seated position.	It is a motor driven, indoorand outdoor transportationvehicle with the intended useto provide mobility to adisabled or elderly personlimited to a seated position.	S.E.
Use condition	indoor and outdoor use	indoor and outdoor use	S.E
Number of wheels	4, including two frontwheels and two rear Wheels	4, including two front wheelsand two rear Wheels	S.E
Function of wheels	Front wheels: drivenwheels suitable for rotation,acceleration, retrograde Rearwheels: driving wheels tocontrol the speed anddirection	Front wheels: driven wheelssuitable for rotation,acceleration, retrograde Rearwheels: driving wheels tocontrol the speed anddirection	S.E
Movement controlmethod	By Joystick control	By Joystick control	S.E
Driving system	Direct drive on the rearwheels	Direct drive on the rearwheels	S.E
Brake system	Automatic electromagneticbrake system	Intelligent regenerativeelectromagnetic brake	S.E
Free-wheel mode	Yes	Yes	S.E
Braking distance	1m	1m	S.E
Maximum safeoperationalincline degree	6°	0-12°	S.E.
Battery charger	Off-board chargerInput: 110-240V, 50/60HzOutput: 24 Vdc, 2A;	Off-board chargerInput: 110-240V, 50/60Hz,Output: 24 Vdc, 2A;	S.E
Main framematerial	Alloy Steel	Aluminum	Analysis:Difference of thematerials will notraise safe andeffectivenessconcerns.
Back cushion	Polyvinyl chloride	PU foam covered by nylonfabric cloth	Thebiocompatibilitytests have beenconducted to verifythe safety andeffectiveness of thematerial.
Seat cushion	Polyvinyl chloride	PU foam covered by nylonfabric cloth
Overall length	870mm	890 mm (35")	Analysis:Minor differences inthe dimensions will
Overall width	710mm	603 mm (23.7")	not impact thesafety andeffectiveness of thesubstantialequivalence.
Stowage length	670mm	324 mm (12.8")
Stowage width	560mm	603 mm (23.7")
Stowage height	615mm	670 mm (26.4")
Front wheelsize/type	7.5"x2" Flat Free Tires	7" x 2" Flat Free Tires	S.E
Rear wheelsize/type	9"x2.7" Flat Free Tires	10" x 2.35" Flat Free Tires	S.E
Max speed Forward	Up to 6 km/h (3.7 mp/ h),adjustable	7 km/h (4.4mph)	Analysis:Slightly differenceon the parameterwill not affect thesafety andperformance of thesubject device as allrelated stability testsare performedaccording tostandard ISO 7176
			6:2018.
Max loadingweight	250 lbs (113.4kg)	220 lbs (100 kg)	S.E
Battery	Lead-acid 24V 20Ah	Li-ion 24V 20Ah	Analysis:The subject devicecomplies with ISO7176-25:2013Wheelchairs - Part25: BatteriesandchargersforpoweredwheelchairsandEMC testing, thesedifferences do notaffect safetyandeffectiveness.
Maximumdistance of travelon the fullycharged battery	8 miles	20 km (12.43miles)	Analysis:The subject devicecomplies with ISO7176-4:2008Wheelchairs - Part4:Energyconsumptionofelectric wheelchairsand scooters fordeterminationoftheoretical distancerange,thesedifferences do notaffect safetyandeffectiveness.
Motor	Brushless DC motor;24VDC; 250W; 2pcs	Brushless DC motor;24VDC; 250W; 2pcs	S.E
Electroniccontroller	Yanteon ElectromechanicalTechnology (Shanghai) Co.,Ltd, Y2450C-JW01, 50A	Yisheng Electric Co. Ltd ,WS-1, 40A	Analysis :Difference onoutput current willaffect charging timeof the subjectdevice, which willnot cause safety andeffectivenessconcerns.
Turning Radius	900mm	800mm	S.E
Maximumobstacle climbing	40 mm	40 mm	S.E
Ground clearance	63.5 mm(2.5")	63.5 mm(2.5")	S.E
Item	Proposed Device	Predicate Devices	Results
Biocompatibility	All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements.(Having long-term skin contactof greater than 30 days)	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.

H. Comparison with predicate Device

Table 1 General Comparison

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

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 Overall & Stowage dimension Max speed Forward, Battery type, Maximum distance of travel on the fully charged battery and Controller output current. 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 (K163204).

Table 2 Safety comparison

Table 3 Safety comparison

{10}------------------------------------------------

{11}------------------------------------------------

J. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission, power wheelchair, JMPW-01W, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K163204.

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 resultsmeet its design specification.	The dynamic stability has beendetermined after the testing accordingto the ISO 7176-2, and test results meetits design specification.	S.E.
ISO7176-3	The effectiveness of brakes has beendetermined after the testing accordingto the ISO 7176-3, and test resultsmeet its design specification.	The effectiveness of brakes has beendetermined after the testing accordingto the ISO 7176-3, and test results meetits design specification.	S.E.
ISO7176-4	The theoretical distance range hasbeen determined after the testingaccording to the ISO 7176-4, and testresults meet its design specification.	The theoretical distance range hasbeen determined after the testingaccording to the ISO 7176-4, and testresults meet its design specification.	S.E.
ISO7176-5	The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5,	The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5,	S.E.
ISO7176-6	The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5,	The dimensions, mass has beendetermined after the testing accordingto 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, 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	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.