(168 days)
Not Found
No
The description details a standard powered wheelchair with remote control capabilities via Bluetooth, but there is no mention of AI or ML for tasks like navigation, obstacle avoidance, or user adaptation.
No
This device is an electric wheelchair, designed to provide mobility for individuals who are limited to a seated position. It does not provide any therapeutic effect or treatment for a disease or condition.
No
The device is an electric wheelchair designed for mobility, not for diagnosing any medical condition. Its intended use is to provide transportation, and it does not perform any diagnostic functions.
No
The device description clearly outlines a physical electric wheelchair with various hardware components (seat system, control system, drive system, motors, battery, brakes). While it includes a smartphone app for remote control, the core device is a physical piece of equipment, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to individuals with limited mobility. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a mechanical and electrical device for transportation, not for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no reagents, assays, or diagnostic procedures described.
- Performance Studies: The performance studies focus on safety, durability, and compliance with standards related to wheelchairs, not diagnostic accuracy or clinical performance related to disease detection or monitoring.
In summary, the Electric Wheelchair (Robooter E60) is a medical device designed for mobility assistance, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
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.
Product codes
ITI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
No clinical study is included in this submission.
Key results: The subjection device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K231868.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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
3
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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4
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
5
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:
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.
6
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.
7
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 of
| Comparison | Subject Device(K240339) | Predicate Device (K231868) | Remark |
|---|---|---|---|
| Manufacturer | Shanghai Bangbang Robotics | ||
| Co., Ltd | Shanghai Bangbang Robotics | ||
| Co., Ltd. | S.E. | ||
| Common or | |||
| Usual 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 for | |||
| use | 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. | The intended use of the | ||
| Electric | |||
| Wheelchair | |||
| (Robooter E40), Model name: | |||
| BBR-E40-01 is to provide | |||
| outdoor and indoor mobility | |||
| to persons limited to a seated | |||
| position that are capable of | |||
| operating a | |||
| powered | |||
| wheelchair. | S.E. | ||
| Product code | ITI | ITI | S.E. |
| Class | II | II | S.E. |
| Regulation | |||
| Number | 21 CFR 890.3860 | 21 CFR 890.3860 | S.E. |
| Common name | Wheelchair, Powered | Wheelchair, Powered | S.E. |
| Type of Use | Over the Counter (OTC | ||
| Only) | Over the Counter (OTC | ||
| Only) | S.E. |
Table 1 General Comparison
| Table 2 Basic Parameters Comparison | |||
|---|---|---|---|
| -- | ------------------------------------- | -- | -- |
| Elements of
Comparison | Subject Device | Predicate Device
(K231868) | Remark |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------|
| Models | BBR-E60-01,
BBR-E60-02,
BBR-E60-05,
BBR-E60-06
BBR-E60-03, BBR-
E60-04, BBR-E60-
07, BBR-E60-08 | BBR-E40-01 | -- |
| Device Length | 980mm | 1000mm | Analysis: |
8
| Device Width | ||||
|---|---|---|---|---|
| Device Width | 640mm | 640mm | 624mm | The predicate device and |
| subject device have different | ||||
| dimensions. Both comply | ||||
| with ISO 7176-5:2008 | ||||
| Wheelchairs - Part 5: | ||||
| Determination of | ||||
| dimensions, mass, and | ||||
| maneuverings space so these | ||||
| differences do not affect | ||||
| safety and effectiveness. | ||||
| Device Height | 932mm | 956mm | 930mm | |
| Stowage Length | 770mm | 855mm | 700mm | |
| Stowage Width | 640mm | 640mm | 624mm | |
| Stowage Height | 500mm | 525mm | 450mm | |
| Number of | ||||
| wheels | 4 | 4 | 4 | S.E. |
| Front Wheel | ||||
| Diameter | 10 in | 12 in | 8 in | Analysis: |
| Both the subject device and | ||||
| the predicate device comply | ||||
| Rear Wheel | ||||
| Diameter | 10 in | 12 in | 10 in | with ISO 7176-7:1998 |
| Wheelchairs - Part 7: | ||||
| Measurement of seating and | ||||
| wheel dimensions, so these | ||||
| differences do not affect | ||||
| safety and effectiveness. | ||||
| Charger | Input: 100-240V AC 50/60Hz | |||
| 2.2A | ||||
| Output: 24V DC 4A | Input: 100-240V AC 50/60Hz | |||
| 2.2A | ||||
| Output: 29.4V DC 3A | S.E. | |||
| Maximum | ||||
| Weight | ||||
| Capacity | 150kg | 150kg | S.E. | |
| Maximum | ||||
| forward speed | ||||
| (maximum safe | ||||
| speed) | 8km/h | 10km/h | 8km/h | Analysis: |
| Both the subject device and | ||||
| the predicate device comply | ||||
| with ISO 7176-6:2018 | ||||
| Wheelchairs - Part 6: | ||||
| Determination of maximum | ||||
| speed, acceleration and | ||||
| deceleration of electric | ||||
| wheelchairs, so these | ||||
| differences do not affect | ||||
| safety and effectiveness. | ||||
| Braking System | Electromagnetic | Electromagnetic | S.E. | |
| Braking | ||||
| mechanism in | ||||
| case of | ||||
| electrical Brake | ||||
| Failure | Normally closed brakes be | |||
| employed. When the device is | ||||
| powered off or when | ||||
| electrical power is lost, the | ||||
| brakes engaged on the motors | Normally closed | |||
| brakes be employed. | ||||
| When the device is | ||||
| powered off or when | ||||
| electrical power is | ||||
| lost, the brakes | ||||
| engaged on the | ||||
| motors to prevent | S.E. | |||
| rotation. | ||||
| Minimum | ||||
| braking distance | ||||
| from max speed | 120cm | 200cm | 102cm | Analysis: |
| Both the subject device and | ||||
| the predicate device comply | ||||
| with ISO 7176-3:2017 | ||||
| Wheelchairs - Part 3: | ||||
| Determination of | ||||
| effectiveness of brakes, so | ||||
| this difference does not | ||||
| affect safety and | ||||
| effectiveness. | ||||
| Turning Radius | 475mm | 500mm | 450mm | Analysis: |
| The predicate device and | ||||
| subject device have different | ||||
| dimensions. Both comply | ||||
| with ISO 7176-5:2008 | ||||
| Wheelchairs - Part 5: | ||||
| Determination of | ||||
| dimensions, mass, and | ||||
| maneuverings space so these | ||||
| differences do not affect | ||||
| safety and effectiveness. | ||||
| Obstacle | ||||
| Climbing | ||||
| Height | 50mm | 50mm | 40mm | |
| Drive system | 2 Wheel Drive (Rear wheel | |||
| drive) | 2 Wheel Drive (Rear | |||
| wheel drive) | S.E. | |||
| folding | ||||
| mechanism | Manually fold/expand | Manually fold/expand | S.E. | |
| Dynamic | ||||
| Stability | 9° | 9° | S.E. | |
| On/Off Button | Yes, Power Button on the | |||
| control pad | Yes, Power Button on | |||
| the control pad | S.E. | |||
| Rocker | ||||
| Location | Right/left can be interchange | Right/left can be | ||
| interchange | S.E. | |||
| Seat Widths | 420mm | 420mm | S.E. | |
| Seat Depths | 430mm | 430mm | S.E. | |
| Back support | ||||
| Height | 460mm | 460mm | S.E. | |
| Operating | ||||
| Conditions | -10°C~50°C | -10°C~50°C | S.E. | |
| Storage | ||||
| Conditions | -20 ° C~60 ° C | -20 ° C~60 ° C | S.E. | |
| Smartphone | ||||
| App | iOS and Android | iOS and Android | S.E. | |
| Wireless RF | ||||
| frequency range | 2.400GHz ~ 2.4835GHz | 2.400GHz ~ | ||
| 2.4835GHz | S.E. | |||
| Wireless RF | ||||
| maximum | ||||
| output power | +4dBm~-20dBm (in 4dB | |||
| steps) | +4dBm~-20dBm (in | |||
| 4dB steps) | S.E. | |||
| Wireless | ||||
| operating range | 10m | 10m | S.E. | |
| Wireless remote | ||||
| control | ||||
| conditions | When chair is occupied or | |||
| unoccupied | When chair is occupied | |||
| or unoccupied | S.E. | |||
| Wireless remote | ||||
| control devices | Smartphone App and | |||
| Bluetooth controller | Smartphone App only | Analysis: | ||
| The subject device has one | ||||
| more remote control method | ||||
| than the predicate device. | ||||
| However, the relevant testing | ||||
| and software has been | ||||
| validated to be effective and | ||||
| safe. | ||||
| Voice function | Notification only | Notification only | S.E. |
9
10
Table 3 Specific Component Comparison
| Elements of
Comparison | Subject Device | Predicate Device
(K231868) | Remark |
|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Battery pack | 1 rechargeable lithium-ion
battery
Ratings: 24 V
20AH
(Models: BBR-E60-01/BBR-
E60-02)
25AH
(Models: BBR-E60-05/BBR-
E60-06) | 1 rechargeable
lithium-ion battery
Ratings: 24 V 20Ah | Analysis:
Both the subject device and
the predicate device comply
with ISO 7176-25:2013
Wheelchairs - Part 25:
Batteries and chargers for
powered wheelchairs, so
these differences do not
affect safety and
effectiveness. |
| Battery weight | 3.33kg(20AH)
3.65kg(25AH) | 3.4kg | |
| Driving Range
(full battery
charge)/
Maximum
distance on fully
battery 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 and
the predicate device comply
with ISO 7176-4: 2008
Wheelchairs - Part 4: Energy
consumption of electric
wheelchairs and scooters for
determination of theoretical
distance range, so these
differences do not affect
safety and effectiveness. |
11
| Adjustable
armrests and
backrest | 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 and
backrest will not affect safety
and performance of the
subject device as all related
stability tests are performed
according to standard ISO
7176 series. |
| ---------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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 contacting | ||
| materials are compliance with | |||
| ISO10993-5, ISO10993-10 and | |||
| ISO 10993-23 requirements. | All user directly contacting | ||
| materials are compliance with | |||
| ISO10993-5, ISO10993-10 and | |||
| ISO 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 ANSI | ||
| C63.27-2017 | wheelchair conforms to ANSI | ||
| C63.27-2017 | S.E. | ||
| Labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. |
Table 4 Safety comparison
| Table 5 Safety comparison | |
|---|---|
| Item | Proposed Device | Predicate Devices | Resu
lts |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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 7176-6 | The dimensions, mass has been
determined after the testing according to
the ISO 7176-6 | S.E. |
| ISO7176-7 | The seating and wheel dimensions has
been determined after the testing
according to the ISO 7176-7 | The seating and wheel dimensions has
been determined after the testing
according to the ISO 7176-7 | S.E. |
| ISO7176-8 | All test results meet the
requirements in Clause 4 of ISO
7176-8 | All test results meet the
requirements in Clause 4 of ISO
7176-8 | S.E. |
| ISO7176-9 | The test results shown that the device
under tests could continue to function
according to manufacturer's
specification after being subjected to
each of the tests specified in Clause 8
of ISO 7176-9 | The test results shown that the device
under tests could continue to function
according to manufacturer's
specification after being subjected to
each of the tests specified in Clause 8
of ISO 7176-9 | S.E. |
| ISO7176-10 | The obstacle-climbing ability of
device has been determined after the
testing according to the ISO 7176-10 | The obstacle-climbing ability of
device has been determined after the
testing according to the ISO 7176-10 | S.E. |
| ISO7176-11 | The test dummies used in the testing of
ISO 7176 series are meet the
requirements of ISO 7176-11 | The test dummies used in the testing of
ISO 7176 series are meet the
requirements of ISO 7176-11 | S.E. |
| ISO7176-13 | The coefficient of friction of test surfaces
has been determined, which could be
used in other 7176 series tests involved | The coefficient of friction of test surfaces
has been determined, which could be
used in other 7176 series tests involved | S.E. |
| ISO7176-14 | All test results meet the requirements
in Clause 7, 8, 9, 10, 11, 12, 13, 14,
15, 17 of ISO 7176-14 | All test results meet the requirements
in Clause 7, 8, 9, 10, 11, 12, 13, 14,
15, 17 of ISO 7176-14 | S.E. |
| | The test results shown that | The test results shown that | S.E. |
| ISO7176-15 | information disclosure, documentation
and labelling of device meet the
requirements of ISO 7176-15 | information disclosure, documentation
and labelling of device meet the
requirements of ISO 7176-15 | |
| ISO 16840-10 | The performance of resistance to
ignition meet the requirements of
ISO 16840-10 | The performance of resistance to
ignition meet the requirements of
ISO 16840-10 | 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. |
12
13
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.