The Power wheelchair BC-EA8000 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 Li-ion Battery pack (24V 6Ah) with 10 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 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 is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for a power wheelchair (Model: BC-EA8000) manufactured by Ningbo Baichen Medical Devices Co., Ltd. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K220747).

It is important to note that this document does not describe an AI/ML medical device. Therefore, information regarding acceptance criteria and studies for AI/ML devices (such as clinical trials, ground truth establishment, expert consensus, MRMC studies, etc.) is not present.

The document primarily relies on non-clinical testing to prove the device meets acceptance criteria, which are defined by adherence to relevant ISO 7176 series standards for wheelchairs.

Here's an analysis based on the provided text, while acknowledging that it's not an AI/ML device submission:

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

The document implicitly defines acceptance criteria by conformity to specific parts of the ISO 7176 series standards. The "reported device performance" is essentially a statement that the device met these standards, and in some cases, provides specific values for comparison with the predicate.

Acceptance Criteria (based on ISO 7176 Series Standards)	Reported Device Performance (as stated in Non-Clinical Test Conclusion & Comparison Tables)
ISO 7176-1: Static stability	Test results meet design specification. (S.E. to predicate)
ISO 7176-2: Dynamic stability	Test results meet design specification. (S.E. to predicate)
ISO 7176-3: Effectiveness of brakes	Test results meet design specification. Braking distance: ≤1.5 m (S.E. to predicate)
ISO 7176-4: Energy consumption & theoretical distance range	Test results meet design specification. Theoretical distance range: 10km (Predicate: 15km, "Analysis" - implying tested and found acceptable)
ISO 7176-5: Overall dimensions, mass & maneuvering space	Test results meet design specification. Overall Dimension: 950625930mm (Predicate: 940610960mm, "Analysis") Folded Dimension: 775440410mm (Predicate: 720310610mm, "Analysis")
ISO 7176-6: Max speed, acceleration & deceleration	Test results meet design specification. Max speed forward: Up to 6 km/h (S.E. to predicate) Max Speed backward: Less than 3 km/h (S.E. to predicate)
ISO 7176-7: Seating and wheel dimensions	Test results meet design specification. Front wheel size/type: 5.9" x1.90" / PU Solid tire (Predicate: 7" x 1.75"/PU Solid tire, "Analysis") Rear wheel size/type: 10.6" x1.97" / PU Solid tire (Predicate: 8.5"x 2"/ PU Solid tire, "Analysis")
ISO 7176-8: Static, impact and fatigue strengths	All test results meet the requirements in Clause 4 of ISO 7176-8. (S.E. to predicate)
ISO 7176-9: Climatic tests	Device continued to function according to manufacturer's specification. (S.E. to predicate)
ISO 7176-10: Obstacle-climbing ability	Test results meet design specification. Maximum obstacle climbing: 40 mm (S.E. to predicate)
ISO 7176-11: Test dummies	Test dummies used meet requirements of ISO 7176-11. (S.E. to predicate)
ISO 7176-13: Coefficient of friction of test surfaces	Test results meet design specification. (S.E. to predicate)
ISO 7176-14: Power and control systems	All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. (S.E. to predicate)
ISO 7176-15: Information disclosure, documentation & labeling	Test results show information disclosure, documentation and labeling meet requirements of ISO 7176-15. (S.E. to predicate)
ISO 7176-16: Resistance to ignition of postural support devices	Performance meets requirements of ISO 7176-16. (S.E. to predicate)
ISO 7176-21: EMC (Electromagnetic compatibility)	EMC performance results meet the requirements of ISO 7176-21. (S.E. to predicate)
ISO 7176-25: Batteries and chargers	Performance of batteries and charger meet the Requirements in Clause 5 and 6 of ISO 7176-25. (S.E. to predicate)
Max safe operational incline degree	6° (Predicate: 9°, "Analysis")
Max loading weight	100 Kg (≈220 lbs) (Predicate: 136kg (≈300 lbs), "Analysis")
Other parameters (materials, motor, battery, joystick, braking system, turning radius, etc.)	Found "S.E." to predicate, indicating comparable performance and safety.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for individual tests. For non-clinical performance testing of physical devices, the sample size is often minimal (e.g., typically one or a few units) unless destructive testing or statistical process control is required. The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications".
Data Provenance: The tests were conducted by the manufacturer, Ningbo Baichen Medical Devices Co., Ltd., in China. The data would be considered prospective, as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a submission for a power wheelchair, not an AI/ML device relying on expert interpretation for ground truth. The acceptance criteria are based on objective performance specifications defined by international standards (ISO 7176 series).

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

Not applicable. This concept pertains to consensus-based evaluation for AI/ML outputs, not physical device performance tests against objective standards.

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 MRMC study was done. This study type is relevant for AI/ML devices where human-in-the-loop performance is evaluated. The submission explicitly states: "No clinical study is included in this submission."

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

Not applicable. This device is a physical power wheelchair, not an algorithm.

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

Ground Truth: The "ground truth" for this device is its demonstrated compliance with pre-defined, objective performance specifications outlined in the ISO 7176 series of international standards. For example, a brake must stop the wheelchair within a certain distance (ISO 7176-3), or the device must withstand specific static and dynamic stability tests (ISO 7176-1, ISO 7176-2). There is no "truth" that requires expert consensus or pathological assessment.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As above, no training set for an AI/ML model.

Summary of the study to prove the device meets acceptance criteria:

The study conducted to prove the power wheelchair meets acceptance criteria was a series of non-clinical performance tests based on the comprehensive ISO 7176 family of standards for wheelchairs. These tests objectively evaluate various aspects of the wheelchair's safety and performance, such as:

Stability: Static and dynamic (ISO 7176-1, ISO 7176-2)
Braking effectiveness: (ISO 7176-3)
Energy consumption and range: (ISO 7176-4)
Dimensions and maneuvering space: (ISO 7176-5)
Speed, acceleration, and deceleration: (ISO 7176-6)
Seating and wheel dimensions: (ISO 7176-7)
Strength and durability: Static, impact, and fatigue (ISO 7176-8)
Environmental performance: Climatic tests (ISO 7176-9)
Obstacle climbing: (ISO 7176-10)
Test dummy specifications: (ISO 7176-11)
Surface friction: (ISO 7176-13)
Power and control systems: (ISO 7176-14)
Labeling and documentation: (ISO 7176-15)
Ignition resistance: (ISO 7176-16)
Electromagnetic compatibility (EMC): (ISO 7176-21)
Battery and charger performance: (ISO 7176-25)

The conclusion of these tests was that the proposed device "met all design specifications" and demonstrated "Substantial Equivalence (SE)" to the predicate device, implying its safety and effectiveness based on these established engineering and performance standards. Differences in specific parameters (e.g., maximum incline, loading weight, dimensions, battery range) were acknowledged but deemed not to "influence the intended use of the device" or have a "deleterious effect on safety and effectiveness," as they were still within acceptable ranges as verified by the ISO standard tests.

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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 15, 2023

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

Re: K232121

Trade/Device Name: Power wheelchair (Model:BC-EA8000) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: July 17, 2023 Received: July 17, 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) K232121

Device Name Power wheelchair (BC-EA8000)

Indications for Use (Describe)

The Power wheelchair BC-EA8000 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)

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Ningbo Baichen Medical Devices Co., Ltd. Room 903, Diqu Building, 666 TaikangMiddle Road, Ningbo, Zhejiang, CN

510(K) Summary K232121

Document Prepared Date: 2023/9/14

Applicant: A.

NINGBO BAICHEN MEDICAL DEVICES CO., LTD.

Address: Room 903, Diqu Building, 666 TaikangMiddle Road, Ningbo, Zhejiang, CN

Contact Person: Wu Xiao Long

Tel: +86 15158388666

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: Power wheelchair Common Name: Powered wheelchair Model: BC-EA8000

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

C. Predicate device:

510Knumber: K220747 Device Name: Power Wheelchair Model: N5515B Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

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Ningbo Baichen Medical Devices Co., Ltd.

Room 903, Diqu Building, 666 TaikangMiddle Road, Ningbo, Zhejiang, CN

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 Li-ion Battery pack (24V 6Ah) with 10 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 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 7176-1: 2014, Wheelchairs Part 1: Determination of static stability >
ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of Powered Wheelchairs
ISO 7176-3: 2012, Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and wheelchairs for determination of theoretical distance range
ISO 7176-5, Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs
ISO 7176-7, Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8:2014, Wheelchairs Part 8: Requirements and test methods for static, impact and > fatigue strengths
ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for Powered Wheelchairs
ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-11:2012 Wheelchairs Part 11: Test dummies. A

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Ningbo Baichen Medical Devices Co., Ltd.

Room 903, Diqu Building, 666 TaikangMiddle Road, Ningbo, Zhejiang, CN

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 ア

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
Common or Usual name	Power Wheelchair	Power Wheelchair	Same
Model(s)	BC-EA8000	N5515B	--
Indications for use	It is a motor driven, indoor andoutdoor transportation vehiclewith the intended use to providemobility to a disabled or elderlyperson limited to a seatedposition.	It is a motor driven, indoor andoutdoor transportation vehiclewith the intended use to providemobility to a disabled or elderlyperson limited to a seatedposition.	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 Rearwheels: driving wheels tocontrol 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 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	Automatic electromagneticbrake system	S.E
Braking distance	≤1.5 m	≤ 1.5 m	S.E
Maximumsafe	6°	9 °	Analysis
operational incline degree
Armrest	PU	PU	S.E
Battery charger	Off-board chargerInput: 100-240V, 50/60Hz, 1.5A,Output: 24 Vdc, 2A;	Off-board chargerInput: 100-240V, 50/60Hz, 1.5A,Output: 24 Vdc, 2A;	S.E
Main frame material	Aluminum Alloy	Carbon fiber material	Analysis
Back cushion	Polyester fabric	Polyester fabric	S.E
Seat cushion	rubber patch cloth and Oxfordfabric	rubber patch cloth and Oxfordfabric	S.E
Overall Dimension(lengthwidthheight)	950625930mm	940610960mm	Analysis
Folded Dimension(lengthwidthheight)	775440410mm	720310610mm	Analysis
Front wheel size/type	5.9" x1.90" / PU Solid tire	7" x 1.75"/PU Solid tire	Analysis
Rear wheel size/type	10.6" x1.97" / PU Solid tire	8.5"x 2"/ PU Solid tire	Analysis
Max speed forward	Up to 6 km/h	Up to 6 km/h (1.6 m/s), adjustable	S.E
Max Speed backward	Less than 3 km/h (0.5 m/s)	Less than 3 km/h (0.5 m/s)	S.E
Max loading weight	100 Kg (≈220 lbs)	136kg (≈300 lbs)	Analysis
Battery	Lithium 24V6Ah	li-ion battery pack; rechargeable, 24 VDC 12Ah	S.E
Maximum distance of travel on the fully charged battery	10km	15 km	Analysis
Motor	Brushless DC motor; 24VDC; 150W, 2pcs	Brushless DC motor; 24VDC; 250W; 2pcs	S.E
Electronic controller	Brushless dual-drive rocker controller	Brushless dual-drive rocker controller	S.E
Turning Radius	900mm	900 mm	S.E
Maximum obstacle climbing	40 mm	40 mm	S.E

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Room 903, Diqu Building, 666 TaikangMiddle Road, Ningbo, Zhejiang, CN

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Ningbo Baichen Medical Devices Co., Ltd. Room 903, Diqu Building, 666 TaikangMiddle Road, Ningbo, Zhejiang, CN

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, Main frame material, Overall Dimension,Folded Dimension, Rear wheel size/type, Max loading weight and Maximum distance of travel on the fully charged battery. 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 (K220747).

The Power Wheelchair BC-EA8000 in its final finished form is identical to the Power Wheelchair (N5515B) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)

Item	Proposed Device	Predicate Devices	Results
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 2 Safety comparison

Table 3 Safety comparison

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Room 903, Diqu Building, 666 TaikangMiddle Road, Ningbo, Zhejiang, CN

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Ningbo Baichen Medical Devices Co., Ltd. Room 903, Diqu Building, 666 TaikangMiddle Road, Ningbo, Zhejiang, CN

J. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, power wheelchair, BC-EA8000, 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 determined after the testing according to the ISO 7176-1, and test results meet its design specification.	The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification.	S.E.
ISO7176-2	The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification.	The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification.	S.E.
ISO7176-3	The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification.	The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification.	S.E.
ISO7176-4	The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification.	The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification.	S.E.
ISO7176-5	The dimensions, mass has been determined after the testing according to the ISO 7176-5,	The dimensions, mass has been determined after the testing according to the ISO 7176-5,	S.E.
ISO7176-6	The dimensions, mass has been determined after the testing according to the ISO 7176-5,	The dimensions, mass has been determined after the testing according to the ISO 7176-5,	S.E.
Room 903, Diqu Building, 666 TaikangMiddle Road, Ningbo, Zhejiang, CN
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.