The intended use of the Electric Wheelchair (Robooter E60), Models name: BBR-E60-01,BBR-E60-02, BBR-E60-03, BBR-E60-04,BBR-E60-05,BBR-E60-06,BBR-E60-07,BBR-E60-08, is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Device Description

The Electric Wheelchair (Robooter E60), Models name: BBR-E60-01, BBR-E60-02, BBR-E60-03, BBR-E60-04, BBR-E60-05, BBR-E60-06, BBR-E60-07, BBR-E60-08, is an indoor/outdoor, batteryoperated, 2-wheel drive (rear-wheel drive) powered wheelchair.

It consists of four modules: seat system, control system, and drive system. The user sits in the wheelchair seat and uses the control system.

The control pad positioned on the right armrest, user can turn the wheelchair on, control the speed, and direct the movement.

The braking system employs an electromagnetic brake, when release the controller rocker, the electromagnetic brakes will be actuated, and the electric wheelchair will stop in several seconds.

Electromagnetic brake will not take effect immediately, it will take effect after the wheel rotates for 1/2 cycle.

The wheelchair is powered by a 24V DC,20Ah or 25Ah rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger. The wheelchair is driven by two DC motors.

The Electric Wheelchair (Robooter E60), Models name: BBR-E60-01, BBR-E60-02, BBR-E60-03, BBR-E60-04, BBR-E60-05, BBR-E60-06, BBR-E60-07, BBR-E60-08, contains Bluetooth 4.1 BLE technology. The device can be controlled by the controller rocker or remote control by a smartphone app via Bluetooth 4.1 Low Energy (BLE) wireless communication interface. The smartphone app is used to drive the chair remotely. For safety, controller rocker control is priority over the remote control by design. The smartphone app can also view the battery's status, adjust the speed gear level and lock/unlock the unattended device.

The wheelchair can be controlled an optional Bluetooth remote controller (BBR-BLERC series)

The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.

AI/ML Overview

The provided documentation is a 510(k) summary for an Electric Wheelchair (Robooter E60). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive details on a comprehensive clinical study to define and meet specific acceptance criteria in the same way one might for a novel diagnostic or therapeutic device.

Based on the provided text, the "acceptance criteria" are primarily defined by compliance with a comprehensive set of ISO 7176 series standards for wheelchairs, along with other relevant ISO and ANSI standards. The "study" proving the device meets these criteria refers to the non-clinical testing performed against these standards.

Here's the breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the requirements set forth by the listed ISO and ANSI standards. The reported device performance is that it met these standards. Since the document doesn't provide specific numerical performance values for each standard (e.g., exact braking distance for a specific test case, or specific stability angles beyond the general 9° dynamic stability), but rather states "test results meet its design specification" or "all test results meet the requirements," a direct comparative table with quantitative acceptance vs. performance for each test is not fully derivable. However, we can represent the overall compliance.

Acceptance Criterion (Standard Requirement)	Reported Device Performance
Biocompatibility: Conforms to ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-23 (Irritation)	All user directly contacting materials are compliant with ISO 10993-5, ISO 10993-10, and ISO 10993-23 requirements.
EMC: Conforms to ISO 7176-21 and IEC 60601-2-1	The EMC performance results meet the requirements of ISO 7176-21.
Static Stability: Conforms to ISO 7176-1	The static stability has been determined, and test results meet its design specification.
Dynamic Stability: Conforms to ISO 7176-2 (e.g., 9° stability)	The dynamic stability has been determined, and test results meet its design specification (9° for proposed and predicate).
Brakes Effectiveness: Conforms to ISO 7176-3	The effectiveness of brakes has been determined, and test results meet its design specification. (Min braking distance: 120cm for subject vs. 200cm for predicate, both compliant with the standard).
Energy Consumption/Range: Conforms to ISO 7176-4	The theoretical distance range has been determined, and test results meet its design specification.
Dimensions, Mass, Maneuvering: Conforms to ISO 7176-5	The dimensions and mass have been determined after testing.
Speed, Acceleration, Deceleration: Conforms to ISO 7176-6	The dimensions and mass have been determined after testing. (Max forward speed: 8km/h for subject vs. 10km/h for predicate, both compliant with the standard).
Seating & Wheel Dimensions: Conforms to ISO 7176-7	The seating and wheel dimensions have been determined after testing.
Static, Impact, Fatigue Strengths: Conforms to ISO 7176-8	All test results meet the requirements in Clause 4 of ISO 7176-8.
Climatic Tests: Conforms to ISO 7176-9	The device 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.
Obstacle-Climbing Ability: Conforms to ISO 7176-10	The obstacle-climbing ability has been determined. (Climbing Height: 50mm for both subject and predicate).
Test Dummies: Conforms to ISO 7176-11	The test dummies used in the testing series meet the requirements of ISO 7176-11.
Coefficient of Friction of Test Surfaces: Conforms to ISO 7176-13	The coefficient of friction of test surfaces has been determined for use in other 7176 series tests.
Power and Control Systems: Conforms to ISO 7176-14	All test results meet the requirements in various clauses of ISO 7176-14.
Information Disclosure, Documentation, Labeling: Conforms to ISO 7176-15	Information disclosure, documentation, and labeling of the device meet the requirements of ISO 7176-15.
Resistance to Ignition of Postural Support Devices: Conforms to ISO 16840-10	The performance of resistance to ignition meets the requirements of ISO 16840-10.
Batteries and Chargers: Conforms to ISO 7176-25	The performance of batteries and charger meets the Requirements in Clause 5 and 6 of ISO 7176-25.
Wireless Coexistence: Conforms to ANSI C63.27-2017	The wheelchair conforms to ANSI C63.27-2017.
Software Verification & Validation	Validation testing of the priority of the on-board "controller rocker" (joystick) over the wireless remote controllers was conducted.

2. Sample Sizes used for the Test Set and Data Provenance

The document does not specify sample sizes (e.g., number of devices tested) for the non-clinical tests. It refers to these as "non-clinical tests" and details the standards followed. The data provenance is implied to be from the manufacturer's testing facilities (Shanghai Bangbang Robotics Co., Ltd.) as part of their submission for market clearance. These are prospective tests conducted to demonstrate compliance. There is no mention of country of origin of the data in terms of patient data, as this is a non-clinical submission.

3. Number of Experts used to establish the Ground Truth for the Test Set and the Qualifications of those Experts

This information is not applicable and not provided. The "ground truth" for non-clinical performance standards is defined by the standards themselves (e.g., a specific static stability angle, braking distance, etc.). Compliance is assessed by accredited testing bodies or manufacturer's internal quality systems against these defined requirements. There are no "experts" in the context of clinical interpretation to establish ground truth in this non-clinical submission.

4. Adjudication Method for the Test Set

This is not applicable to non-clinical technical performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple human readers (e.g., radiologists) to establish a consensus ground truth when individual reader opinions might differ.

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 done or reported. This submission is for an electric wheelchair, a physical medical device, not an AI-powered diagnostic or interpretive tool that would involve human readers. The document 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

This is not applicable. The device is an electric wheelchair, not an algorithm, and the testing focuses on its physical and electrical safety and performance characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is the performance metrics and criteria defined within the referenced international standards (ISO 10993, ISO 7176 series, ANSI C63.27) and the device's design specifications. For example, for static stability, the ground truth is the minimum stability angle specified by ISO 7176-1. For braking, it's the effectiveness criteria of ISO 7176-3.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reason as point 8.

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 22, 2024

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

Re: K240339

Trade/Device Name: Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03): Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06): Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)

Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 17, 2024 Received: June 17, 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 medical devices and radiation-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

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Assistant Director 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 Health

Enclosure

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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)	K240339
Device Name	Electric Wheelchair (Robooter E60) (BBR-E60-01);
	Electric Wheelchair (Robooter E60) (BBR-E60-02);
	Electric Wheelchair (Robooter E60) (BBR-E60-03);
	Electric Wheelchair (Robooter E60) (BBR-E60-04);
	Electric Wheelchair (Robooter E60) (BBR-E60-05);
	Electric Wheelchair (Robooter E60) (BBR-E60-06);
	Electric Wheelchair (Robooter E60) (BBR-E60-07);
	Electric Wheelchair (Robooter E60) (BBR-E60-08)
Indications for Use (Describe)	The intended use of the Electric Wheelchair (Robooter E60), Models name: BBR-E60-01,BBR-E60-02, BBR-E60-03, BBR-E60-04,BBR-E60-05,BBR-E60-06,BBR-E60-07,BBR-E60-08, is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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510(K) Summary K240339

Document Prepared Date: 2024/7/19

Applicant: A.

Shanghai BangBang Robotics Co., Ltd.

Address: Room 501, Building 3, No.188 Zhongchen Road, Songjiang District, Shanghai,

China.

Contact Person: Canfeng Liu Tel: +86-13524910052

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 (Robooter E60) Common Name: Powered wheelchair Models: BBR-E60-01, BBR-E60-02, BBR-E60-03, BBR-E60-04, BBR-E60-05, BBR-E60-06, BBR-E60-07, BBR-E60-08.

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

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Review Panel: Physical Medicine

C. Predicate device:

510K number: K231868 Device Name: Electric Wheelchair (Robooter E40) Model: BBR-E40-01 Shanghai BangBang Robotics Co., Ltd.

D. Indications for use of the device:

The intended use of the Electric Wheelchair (Robooter E60), Models name: BBR-E60-01, BBR-E60-02, BBR-E60-03, BBR-E60-04, BBR-E60-05, BBR-E60-07, BBR-E60-07, BBR-E60-08, is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

E. Device Description:

It consists of four modules: seat system, control system, and drive system. The user sits in the wheelchair seat and uses the control system.

The control pad positioned on the right armrest, user can turn the wheelchair on, control the speed, and direct the movement.

The braking system employs an electromagnetic brake, when release the controller rocker, the electromagnetic brakes will be actuated, and the electric wheelchair will stop in several seconds.

Electromagnetic brake will not take effect immediately, it will take effect after the wheel rotates for 1/2 cycle.

The wheelchair is powered by a 24V DC,20Ah or 25Ah rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger. The wheelchair is driven by two DC motors.

The wheelchair can be controlled an optional Bluetooth remote controller (BBR-BLERC series)

The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.

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F. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro ♪ Cytotoxicity
ISO 10993-10: 2021 Biological Evaluation of Medical Devices Part 10: Tests For 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 >
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 maneuvering space
ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs
ISO 7176-7:1998, 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 A of friction of test surfaces
ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and wheelchairs - Requirements and test methods
ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 16840-10:2021 Wheelchair seating Part 10: Resistance to ignition of postural support devices > Requirements 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 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence >
Software verification & validation testing, including validation testing of the priority of the on-> board "controller rocker" (joystick) over the wireless remote controllers

G. Clinical Test Conclusion

No clinical study is included in this submission.

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H. Comparison with predicate Device

Compared to the predicate devices, the subject device has the same intended use, similar product design, similar performance, same safety as the predicate device, the summarized comparison information is listed in the following table

Elements ofComparison	Subject Device(K240339)	Predicate Device (K231868)	Remark
Manufacturer	Shanghai Bangbang RoboticsCo., Ltd	Shanghai Bangbang RoboticsCo., Ltd.	S.E.
Common orUsual name	Powered Wheelchair	Powered Wheelchair	S.E.
Model(s)	BBR-E60-01,BBR-E60-02,BBR-E60-03, BBR-E60-04,BBR-E60-05,BBR-E60-06,BBR-E60-07,BBR-E60-08	BBR-E40-01	--
Indications foruse	The intended use of theElectricWheelchair(Robooter E60), Modelsname: BBR-E60-01,BBR-E60-02, BBR-E60-03, BBR-E60-04,BBR-E60-05,BBR-E60-06,BBR-E60-07,BBR-E60-08, is to provide outdoorand indoor mobility topersons limited to a seatedposition that are capable ofoperating apoweredwheelchair.	The intended use of theElectricWheelchair(Robooter E40), Model name:BBR-E40-01 is to provideoutdoor and indoor mobilityto persons limited to a seatedposition that are capable ofoperating apoweredwheelchair.	S.E.
Product code	ITI	ITI	S.E.
Class	II	II	S.E.
RegulationNumber	21 CFR 890.3860	21 CFR 890.3860	S.E.
Common name	Wheelchair, Powered	Wheelchair, Powered	S.E.
Type of Use	Over the Counter (OTCOnly)	Over the Counter (OTCOnly)	S.E.

Table 1 General Comparison

	Table 2 Basic Parameters Comparison
--	-------------------------------------	--	--

Elements ofComparison	Subject Device	Predicate Device(K231868)	Remark
Models	BBR-E60-01,BBR-E60-02,BBR-E60-05,BBR-E60-06BBR-E60-03, BBR-E60-04, BBR-E60-07, BBR-E60-08	BBR-E40-01	--
Device Length	980mm	1000mm	Analysis:

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Device Width
Device Width	640mm	640mm	624mm	The predicate device andsubject device have differentdimensions. Both complywith ISO 7176-5:2008Wheelchairs - Part 5:Determination ofdimensions, mass, andmaneuverings space so thesedifferences do not affectsafety and effectiveness.
Device Height	932mm	956mm	930mm
Stowage Length	770mm	855mm	700mm
Stowage Width	640mm	640mm	624mm
Stowage Height	500mm	525mm	450mm
Number ofwheels	4	4	4	S.E.
Front WheelDiameter	10 in	12 in	8 in	Analysis:Both the subject device andthe predicate device comply
Rear WheelDiameter	10 in	12 in	10 in	with ISO 7176-7:1998Wheelchairs - Part 7:Measurement of seating andwheel dimensions, so thesedifferences do not affectsafety and effectiveness.
Charger	Input: 100-240V AC 50/60Hz2.2AOutput: 24V DC 4A	Input: 100-240V AC 50/60Hz2.2AOutput: 29.4V DC 3A		S.E.
MaximumWeightCapacity	150kg	150kg		S.E.
Maximumforward speed(maximum safespeed)	8km/h	10km/h	8km/h	Analysis:Both the subject device andthe predicate device complywith ISO 7176-6:2018Wheelchairs - Part 6:Determination of maximumspeed, acceleration anddeceleration of electricwheelchairs, so thesedifferences do not affectsafety and effectiveness.
Braking System	Electromagnetic	Electromagnetic		S.E.
Brakingmechanism incase ofelectrical BrakeFailure	Normally closed brakes beemployed. When the device ispowered off or whenelectrical power is lost, thebrakes engaged on the motors	Normally closedbrakes be employed.When the device ispowered off or whenelectrical power islost, the brakesengaged on themotors to prevent		S.E.
			rotation.
Minimumbraking distancefrom max speed	120cm	200cm	102cm	Analysis:Both the subject device andthe predicate device complywith ISO 7176-3:2017Wheelchairs - Part 3:Determination ofeffectiveness of brakes, sothis difference does notaffect safety andeffectiveness.
Turning Radius	475mm	500mm	450mm	Analysis:The predicate device andsubject device have differentdimensions. Both complywith ISO 7176-5:2008Wheelchairs - Part 5:Determination ofdimensions, mass, andmaneuverings space so thesedifferences do not affectsafety and effectiveness.
ObstacleClimbingHeight	50mm	50mm	40mm
Drive system	2 Wheel Drive (Rear wheeldrive)		2 Wheel Drive (Rearwheel drive)	S.E.
foldingmechanism	Manually fold/expand		Manually fold/expand	S.E.
DynamicStability	9°		9°	S.E.
On/Off Button	Yes, Power Button on thecontrol pad		Yes, Power Button onthe control pad	S.E.
RockerLocation	Right/left can be interchange		Right/left can beinterchange	S.E.
Seat Widths	420mm		420mm	S.E.
Seat Depths	430mm		430mm	S.E.
Back supportHeight	460mm		460mm	S.E.
OperatingConditions	-10°C~50°C		-10°C~50°C	S.E.
StorageConditions	-20 ° C~60 ° C		-20 ° C~60 ° C	S.E.
SmartphoneApp	iOS and Android		iOS and Android	S.E.

Wireless RFfrequency range	2.400GHz ~ 2.4835GHz	2.400GHz ~2.4835GHz	S.E.
Wireless RFmaximumoutput power	+4dBm~-20dBm (in 4dBsteps)	+4dBm~-20dBm (in4dB steps)	S.E.
Wirelessoperating range	10m	10m	S.E.
Wireless remotecontrolconditions	When chair is occupied orunoccupied	When chair is occupiedor unoccupied	S.E.
Wireless remotecontrol devices	Smartphone App andBluetooth controller	Smartphone App only	Analysis:The subject device has onemore remote control methodthan the predicate device.However, the relevant testingand software has beenvalidated to be effective andsafe.
Voice function	Notification only	Notification only	S.E.

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Table 3 Specific Component Comparison

Elements ofComparison	Subject Device	Predicate Device(K231868)	Remark
Battery pack	1 rechargeable lithium-ionbatteryRatings: 24 V20AH(Models: BBR-E60-01/BBR-E60-02)25AH(Models: BBR-E60-05/BBR-E60-06)	1 rechargeablelithium-ion batteryRatings: 24 V 20Ah	Analysis:Both the subject device andthe predicate device complywith ISO 7176-25:2013Wheelchairs - Part 25:Batteries and chargers forpowered wheelchairs, sothese differences do notaffect safety andeffectiveness.
Battery weight	3.33kg(20AH)3.65kg(25AH)	3.4kg
Driving Range(full batterycharge)/Maximumdistance on fullybattery charge	21.1km(Models:BBR-E60-01/BBR-E60-02)25.3km(Models:BBR-E60-05/BBR-E60-06)	21.5km	Analysis:Both the subject device andthe predicate device complywith ISO 7176-4: 2008Wheelchairs - Part 4: Energyconsumption of electricwheelchairs and scooters fordetermination of theoreticaldistance range, so thesedifferences do not affectsafety and effectiveness.

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Adjustablearmrests andbackrest	Not adjustable(Models: BBR-E60-01/ BBR-E60-03/ BBR-E60-05/ BBR-E60-07)Manually adjustable(Models:BBR-E60-02/ BBR-E60-04/ BBR-E60-06/ BBR-E60-08)	Not adjustable	Analysis:Adjustability of armrests andbackrest will not affect safetyand performance of thesubject device as all relatedstability tests are performedaccording to standard ISO7176 series.
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Substantially Equivalence Discussion:

The design and technological characteristics of the Electric Wheelchair (Robooter E60) is similar to the predicates chosen. There are minor differences between the devices including Folded & Unfolded dimension, Front & Rear wheel diameter, Maximum forward speed (maximum safe speed), Minimum braking distance from max speed, Turning Radius, Obstacle Climbing Height, Battery capacity & weight, Driving Range and Adjustable armrests and backrest. 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 Electric Wheelchair (Robooter E40) (K231868).

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, ISO10993-10 andISO 10993-23 requirements.	S.E.
EMC	ISO7176-21 & IEC 60601-2-1	ISO7176-21	S.E.
Performance	ISO7176 series	ISO7176 series	S.E.
Wireless coexistence	wheelchair conforms to ANSIC63.27-2017	wheelchair conforms to ANSIC63.27-2017	S.E.
Labeling	Conforms to FDA Regulatory	Conforms to FDA Regulatory	S.E.

Table 4 Safety comparison

	Table 5 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 (Robooter E60), Models name: BBR-E60-01,BBR-E60-02, BBR-E60-03, BBR-E60-04,BBR-E60-05,BBR-E60-06,BBR-E60-07,BBR-E60-08, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K231868.

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.
	The test results shown that	The test results shown that	S.E.
ISO7176-15	information disclosure, documentationand labelling of device meet therequirements of ISO 7176-15	information disclosure, documentationand labelling of device meet therequirements of ISO 7176-15
ISO 16840-10	The performance of resistance toignition meet the requirements ofISO 16840-10	The performance of resistance toignition meet the requirements ofISO 16840-10	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.
ISO7176-25	The performance of batteries and chargerof device meet the Requirements inClause 5 and 6 of ISO 7176-25	The performance of batteries and chargerof device meet the Requirements inClause 5 and 6 of ISO 7176-25	S.E.