Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)

K240913 · Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd · ITI · May 31, 2024 · Physical Medicine

Device Facts

• Record ID: K240913
• Device Name: Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)
• Applicant: Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd
• Product Code: ITI · Physical Medicine
• Decision Date: May 31, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Intended Use

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Device Story

Electric Wheelchair (models HBLD3-B, HBLD3-E) is a motor-driven, indoor/outdoor mobility vehicle for disabled or elderly users. Device components include frame, front/drive wheels, controller, motors, armrests, backrest, seat cushion, seatbelt, pedals, and Li-ion battery pack. User operates device via joystick controller to manage speed and direction. Releasing joystick triggers automatic electronic braking system. Device powered by rechargeable Li-ion battery (20 km range); off-board charger connects to AC outlet. Device assists users with mobility limitations in daily movement. No clinical data included.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 7176 series (stability, braking, energy consumption, dimensions, strength, climatic, obstacle climbing, EMC) and ISO 10993 (biocompatibility) demonstrated.

Technological Characteristics

Powered wheelchair; aluminum alloy frame; brushless DC motors (24VDC, 150W x 2); Li-ion battery (24VDC, 5.2Ah x 2); joystick controller; automatic electronic braking; PU solid front tires; pneumatic rear tires. Connectivity: off-board charger (100-240V AC). Standards: ISO 7176 series, ISO 10993-5/10/23, ISO 16840-10.

Indications for Use

Indicated for disabled or elderly persons with mobility difficulties who are limited to a seated position.

Regulatory Classification

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.

Predicate Devices

• Power Wheelchair Model: N5515B Zhejiang Innuovo Rehabilitation Devices Co.,Ltd (K220747)

Reference Devices

• Power Wheelchair Model: DC01 Anhui JBH Medical Apparatus Co., Ltd (K212092)

Submission Summary (Full Text)

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May 31, 2024

Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd. % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, Shanghai 200122 China

Re: K240913

Trade/Device Name: Electric Wheelchair (HBLD3-B): Electric Wheelchair (HBLD3-E) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 3, 2024 Received: April 3, 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/cdrb/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 ([e-mail]) or phone [phone] 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

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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

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

Submission Number (if known)

K240913

Device Name

Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)

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)

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# Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd 1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China 510(K) Summary K240913

#### Document Prepared Date: 2024/5/20

Applicant: A.

Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd Address: 1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China Contact Person: Joy Ding Tel: [phone]

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: [phone] Email: [e-mail]

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: [phone] Email: zxfda(@sungoglobal.com

#### B. Device:

Trade Name: Electric Wheelchair Common Name: Powered wheelchair Models: HBLD3-B, HBLD3-E

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

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#### Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd 1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China

#### C. Predicate device:

510Knumber: K220747

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

# D. Reference device:

510Knumber: K212092

Device Name: Power Wheelchair Model: DC01

Anhui JBH Medical Apparatus Co., Ltd

# E. 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.

# F. Device Description:

This Electric Wheelchair, models: HBLD3-B, HBLD3-E, 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 20 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 will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electronic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

# G. 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 10993-10:2021 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
- 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 >

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Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd

1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China

- > 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 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 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 7176-21:2009 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

# H. Clinical Test Conclusion

No clinical study is included in this submission.

#### Comparison with predicate Device L

| Elements of<br>Comparison | Subject Device<br>(K240913) | Predicate Device<br>(K220747) | Reference<br>Device(K212092) | Remark |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Manufacturer | Shanghai Hubang<br>Intelligent<br>Rehabilitation<br>Equipment Co., Ltd | Zhejiang Innuovo<br>Rehabilitation<br>Devices Co.,Ltd | Anhui JBH Medical<br>Apparatus Co., Ltd | - |
| Common or Usual<br>name | Power Wheelchair | Power Wheelchair | Power Wheelchair | Same |
| Model(s) | HBLD3-B, HBLD3-E | N5515B | DC01 | -- |
| Indications for use | It is a motor driven,<br>indoor and outdoor<br>transportation vehicle<br>with the intended use<br>to provide mobility to<br>a disabled or elderly<br>person limited to a<br>seated position. | It is a motor driven,<br>indoor and outdoor<br>transportation vehicle<br>with the intended use<br>to provide mobility to<br>a disabled or elderly<br>person limited to a<br>seated position. | It is a motor<br>driven, indoor and<br>outdoor<br>transportation vehicle<br>with the intended use<br>to provide mobility to<br>a disabled or elderly<br>person limited to<br>a seated position. | S.E. |
| Use condition | indoor and outdoor<br>use | indoor and outdoor<br>use | indoor and outdoor<br>use | S.E |
| Number of wheels | 4, including two front<br>wheels and two rear<br>Wheels | 4, including two front<br>wheels and two rear<br>Wheels | 4, including two front<br>wheels and two rear<br>Wheels | S.E |
| Function of wheels | Front wheels: driven<br>wheels suitable for<br>rotation, acceleration,<br>retrograde.<br>Rear wheels: driving<br>wheels to control the<br>speed and direction | Front wheels: driven<br>wheels suitable for<br>rotation, acceleration,<br>retrograde.<br>Rear wheels: driving<br>wheels to control the<br>speed and direction | Front wheels:<br>driven wheels<br>suitable for rotation,<br>acceleration,<br>retrograde.<br>Rear wheels: driving<br>wheels to control the<br>speed and direction | S.E |
| Movement control<br>method | By Joystick control | By Joystick control | By Joystick control | S.E |
| Driving system | Direct drive on the<br>rear<br>wheels | Direct drive on the<br>rear wheels | Direct drive on<br>the rear wheels | S.E |
| Brake system | Automatic electronic<br>brake system | Automatic<br>electromagnetic<br>brake system | Automatic<br>electromagnetic<br>brake system | S.E |
| Braking distance | ≤1.5 m | ≤1.5 m | ≤1.5 m | S.E |
| Maximum safe<br>operational incline<br>degree | 3 ° | 9 ° | 8 ° | Analysis |
| Armrest | ABS | PU | PU (polyurethane) | Analysis |
| Battery charger | Off-board charger<br>Input: 100-240V,<br>50/60Hz, 1.5A,<br>Output: 24 Vdc, 2A; | Off-board charger<br>Input: 100-240V,<br>50/60Hz, 1.5A,<br>Output: 24 Vdc, 2A; | Off-board charger<br>Input: 100-240V,<br>50/60Hz, 1.5A,<br>Output: 24 Vdc, 2A; | S.E |
| Main frame material | Aluminum Alloy | Carbon fiber material | Aluminum Alloy | Analysis |
| Back cushion | Polyester fabric | Polyester fabric | linen cloth filled<br>with PU foam | S.E |
| Seat cushion | Polyester fabric | rubber patch cloth<br>and Oxford fabric | linen cloth filled<br>with PU foam | Analysis |
| Overall Dimension<br>(length*width*height) | HBLD3-B model:<br>960*580*890 mm<br>HBLD3-E model:<br>1090*640*900 mm | 940*610*960mm | N/A | S.E |
| Folded Dimension<br>(length*width*height) | HBLD3-B model:<br>890*600*380 mm<br>HBLD3-E model:<br>730*350*950 mm | 720*310*610mm | N/A | S.E |
| Front wheel<br>size/type | 7" x 1.75"/PU Solid<br>tire | 7" x 1.75"/PU Solid<br>tire | 7" x 1.75" /PU Solid<br>tire | S.E |
| Rear wheel size/type | 12" x 2.125"<br>pneumatic tire | 8.5" x 2" / PU Solid<br>tire | 8"x1.95" /PU solid<br>tires | Analysis |
| Max speed forward | 6.12 km/h | Up to 6 km/h<br>(1.6m/s), adjustable | 3.75 mph (6 km/h) | Analysis |
| Max Speed<br>backward | Less than 3 km/h<br>(0.8m/s) | Less than 3 km/h<br>(0.8m/s) | N/A | S.E |
| Max loading weight | 100 kg | 136 kg | 136 kg | Analysis |
| Battery | Li-ion battery pack;<br>rechargeable, 24 VDC<br>5.2 Ah*2 | Li-ion battery pack;<br>rechargeable, 24<br>VDC 12Ah | Lithium-ion,<br>24V6Ah, 6Ah x<br>24 VDC | Analysis |
| Maximum<br>distance<br>of travel on the fully<br>charged battery | 20km | 15 km | 20km | Analysis |
| Motor | Brushless DC motor;<br>24VDC; 150W; 2pcs | Brushless DC motor;<br>24VDC; 250W; 2pcs | Brushless DC motor<br>180W x 24 VDC x 2<br>pcs | S.E |
| Electronic controller | Brushless dual-drive<br>rocker controller | Brushless dual-drive<br>rocker controller | Brushless dual-drive<br>rocker controller | S.E |
| Turning radius | HBLD3-B model: 875<br>mm<br>HBLD3-E model:<br>1050 mm | 900 mm | 800 mm | Analysis |
| Maximum obstacle<br>climbing | 20mm | 40 mm | 20mm | Analysis |

#### Table 1 General Comparison

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Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd 1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China

# 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 cushion, Rear wheel size/type, Max speed forward, 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

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# Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd 1188 Xiangyang Road, Zhuanqiao, Minhang District, Shanghai 201108, P. R. China

10993 series.

# Table 2 Safety comparison

| Item | Proposed Device | Predicate Devices | Results |
|--------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------|
| Biocompatibility | All user directly contacting<br>materials are compliance with<br>ISO10993-5, ISO10993-10 and<br>ISO 10993-23 requirements. | All user directly contacting<br>materials are compliance with<br>ISO10993-5 and<br>ISO10993-10 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

| Item | Proposed Device | Predicate Devices | Results |
|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ISO7176-1 | The Static stability has been determined<br>after the testing according to the ISO<br>7176-1, and test results meet its design<br>specification. | The Static stability has been determined<br>after the testing according to the ISO<br>7176-1, and test results meet its design<br>specification. | S.E. |
| ISO7176-2 | The dynamic stability has been<br>determined after the testing according to<br>the ISO 7176-2, and test results meet its<br>design specification. | The dynamic stability has been<br>determined after the testing according to<br>the ISO 7176-2, and test results meet its<br>design specification. | S.E. |
| ISO7176-3 | The effectiveness of brakes has been<br>determined after the testing according to<br>the ISO 7176-3, and test results meet its<br>design specification. | The effectiveness of brakes has been<br>determined after the testing according to<br>the ISO 7176-3, and test results meet its<br>design specification. | S.E. |
| ISO7176-4 | The theoretical distance range has been<br>determined after the testing according<br>to the ISO 7176-4, and test results meet<br>its design specification. | The theoretical distance range has been<br>determined after the testing according<br>to the ISO 7176-4, and test results meet<br>its design specification. | S.E. |
| ISO7176-5 | The dimensions, mass has been<br>determined after the testing according to<br>the ISO 7176-5 | The dimensions, mass has been<br>determined after the testing according to<br>the ISO 7176-5 | S.E. |
| ISO7176-6 | The dimensions, mass has been<br>determined after the testing according to<br>the ISO 7176-6 | The dimensions, mass has been<br>determined after the testing according to<br>the ISO 7176-6 | S.E. |
| ISO7176-7 | The seating and wheel dimensions has<br>been determined after the testing<br>according to the ISO 7176-7 | The seating and wheel dimensions has<br>been determined after the testing<br>according to the ISO 7176-7 | S.E. |
| ISO7176-8 | All test results meet the<br>requirements in Clause 4 of ISO<br>7176-8 | All test results meet the<br>requirements in Clause 4 of ISO<br>7176-8 | S.E. |

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| 1188 Xiangyang Road, Zhuanqiao, Minnang District, Shanghai 201108, P. R. China | | | |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| ISO7176-9 | The test results shown that the device<br>under tests could continue to function<br>according to manufacturer's<br>specification after being subjected to<br>each of the tests specified in Clause 8<br>of ISO 7176-9 | The test results shown that the device<br>under tests could continue to function<br>according to manufacturer's<br>specification after being subjected to<br>each of the tests specified in Clause 8<br>of ISO 7176-9 | S.E. |
| ISO7176-10 | The obstacle-climbing ability of<br>device has been determined after the<br>testing according to the ISO 7176-10 | The obstacle-climbing ability of<br>device has been determined after the<br>testing according to the ISO 7176-10 | S.E. |
| ISO7176-11 | The test dummies used in the testing of<br>ISO 7176 series are meet the<br>requirements of ISO 7176-11 | The test dummies used in the testing of<br>ISO 7176 series are meet the<br>requirements of ISO 7176-11 | S.E. |
| ISO7176-13 | The coefficient of friction of test surfaces<br>has been determined, which could be<br>used in other 7176 series tests involved | The coefficient of friction of test surfaces<br>has been determined, which could be<br>used in other 7176 series tests involved | S.E. |
| ISO7176-14 | All test results meet the requirements<br>in Clause 7, 8, 9, 10, 11, 12, 13, 14,<br>15, 17 of ISO 7176-14 | All test results meet the requirements<br>in Clause 7, 8, 9, 10, 11, 12, 13, 14,<br>15, 17 of ISO 7176-14 | S.E. |
| ISO7176-15 | The test results shown that<br>information disclosure, documentation<br>and labelling of device meet the<br>requirements of ISO 7176-15 | The test results shown that<br>information disclosure, documentation<br>and labelling of device meet the<br>requirements of ISO 7176-15 | S.E. |
| ISO7176-16/<br>ISO 16840-<br>10 | The performance of resistance to<br>ignition meet the requirements of<br>ISO 16840-10 | The performance of resistance to<br>ignition meet the requirements of<br>ISO 7176-16 | S.E. |
| ISO 7176-21 | The EMC performance results meet the<br>requirements of ISO 7176-21 | The EMC performance results meet the<br>requirements of ISO 7176-21 | S.E. |

# J. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Electric Wheelchair, models: HBLD3-E, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K220747.