Electric Wheelchair (JLE-W01A-2023)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". August 7, 2024 Zhejiang Jianrui Technology Company Limited % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, Shanghai 200122 China Re: K240255 Trade/Device Name: Electric Wheelchair (JLE-W01A-2023) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: July 2, 2024 Received: July 2, 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 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" {1}------------------------------------------------ (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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). #### Sincerely. Julia E. Slocomb - 2024.08.07 13:54:28 -04'00' റ for Tushar Bansal, PhD Team Lead, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality {2}------------------------------------------------ Center for Devices and Radiological Health {3}------------------------------------------------ ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K240255 Device Name Electric Wheelchair (JLE-W01A-2023) 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China. # 510(K) Summary K240255 # Document Prepared Date: 2024/8/2 ### A. Applicant: Zhejiang Jianrui Technology Company Limited. Address: Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China. Contact Person: Zhihong Lyu Tel: +86-15967906572 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 (JLE-W01A-2023) Common Name: Powered wheelchair Model: JLE-W01A-2023 Regulatory Information Classification Name: Powered wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine ### C. Predicate device: {5}------------------------------------------------ Zhejiang Jianrui Technology Company Limited. Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China. 510Knumber: K220747 Device Name: Power Wheelchair Model: N5515B Zhejiang Innuovo Rehabilitation Devices Co.,Ltd # D. Indications for use of the device: Electric Wheelchair (JLE-W01A-2023) is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. # E. Device Description: This Electric Wheelchair (JLE-W01A-2023), 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, charger and anti-tip wheels. The device is powered by Li-ion Battery pack with 27.5 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, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized. Anti-tip wheel is a safety device to prevent the wheelchair from turning over when driving on the slope. When the operator needs to use the subject electric wheelchair, he must pull down the anti-tip wheels. # 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 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 > - > 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 > {6}------------------------------------------------ #### Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China. dimensions, mass and manoeuvring space - > ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs - > ISO 7176-7, Wheelchairs - Part 7: Measurement of seating and wheel dimensions - ISO 7176-8:2014, Wheelchairs Part 8: Requirements and test methods for static, impact and > fatigue strengths - ISO 7176-9:2009, Wheelchairs Part 9: Climatic tests for Powered Wheelchairs > - > ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs - ISO 7176-11:2012 Wheelchairs Part 11: Test dummies. ア - > 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 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 7176-25:2022 Wheelchairs Part 25: Lead-acid batteries and chargers for powered wheelchairs > - Requirements and test methods > - > IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium Systems ### G. Clinical Test Conclusion No clinical study is included in this submission. ### H. Comparison with predicate Device #### Table 1 General Comparison | Elements of<br>Comparison | Subject Device | Predicate Device (K220747) | Remark | |---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Manufacturer | Zhejiang Jianrui Technology<br>Company Limited. | Zhejiang Innuovo<br>Rehabilitation Devices Co.,Ltd | - | | Common or Usual<br>name | Power Wheelchair | Power Wheelchair | Same | | Model(s) | JLE-W01A-2023 | N5515B | -- | | Indications for use | Electric Wheelchair (JLE-W01A-<br>2023) is a motor driven, indoor and<br>outdoor transportation vehicle with<br>the intended use to provide<br>mobility to a disabled or elderly<br>person limited to a seated position. | It is a motor driven, indoor and<br>outdoor transportation vehicle<br>with the intended use to provide<br>mobility to a disabled or elderly<br>person limited to a seated<br>position. | S.E. | | Use condition | indoor and outdoor use | indoor and outdoor use | S.E | | Number of wheels | 4, including two front wheels and<br>two rear Wheels | 4, including two front wheels<br>and two rear Wheels | S.E | | Function of wheels | Front wheels: driven wheels<br>suitable for rotation, acceleration,<br>retrograde.<br>Rear wheels: driving wheels to<br>control the speed and direction | Front wheels: driven wheels<br>suitable for rotation,<br>acceleration, retrograde.<br>Rear wheels: driving wheels to<br>control the speed and direction | S.E | | Movement control<br>method | By Joystick control | By Joystick control | S.E | | Driving system | Direct drive on the rear<br>wheels | Direct drive on the rear<br>wheels | S.E | | Brake system | Automatic electromagnetic<br>brake system | Automatic electromagnetic<br>brake system | S.E | | Braking distance | 1.2m | 1.5 m | Analysis | | Maximum safe<br>operational incline<br>degree | 6° | 9° | Analysis | | Armrest | PVC | PU | Analysis | | Battery charger | Off-board charger<br>Input: 100-240VAC, 50/60Hz, 2A;<br>Output: 29.4V, 2A | Off-board charger<br>Input: 100-240V, 50/60Hz, 1.5A,<br>Output: 24 Vdc, 2A; | Analysis | | Main frame material | Carbon fiber material | Carbon fiber material | S.E | | Back cushion | Synthetic fiber polyester | Polyester fabric | Analysis | | Seat cushion | Synthetic fiber polyester | rubber patch cloth and Oxford<br>fabric | Analysis | | Overall Dimension<br>(length*width*height) | 1020*700*890mm | 940*610*960mm | Analysis | | Folded Dimension<br>(length*width*height) | 700*740*520mm | 720*310*610mm | Analysis | | Front wheel size/type | 8" x 2"/PU Solid tire | 7" x 1.75"/PU Solid tire | Analysis | | Rear wheel size/type | 10"x 2"/ PU Pneumatic tire | 8.5"x 2"/ PU Solid tire | Analysis | | Max speed forward | Up to 6 km/h (1.6 m/s), adjustable | Up to 6 km/h (1.6 m/s),<br>adjustable | S.E | | Max Speed backward | Less than 3 km/h (0.5 m/s) | Less than 3 km/h (0.5 m/s) | S.E | | Max loading weight | 100kg | 136kg | Analysis | | Battery | Li-ion battery pack; rechargeable, 24 VDC 15Ah | Li-ion battery pack; rechargeable, 24 VDC 12Ah | S.E | | Maximum distance of travel on the fully charged battery | 27.5 km | 15 km | Analysis | | Motor | Brushless DC motor; 24VDC; 150W; 2pcs | Brushless DC motor; 24VDC; 250W; 2pcs | Analysis | | Electronic controller | Brushless motor controller | Brushless dual-drive rocker controller | S.E | | Turning Radius | 913mm | 900 mm | Analysis | | Maximum obstacle climbing | 35mm | 40 mm | S.E | {7}------------------------------------------------ Zhejiang Jianrui Technology Company Limited. Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China. {8}------------------------------------------------ Zhejiang Jianrui Technology Company Limited. Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China. ### Difference analysis: The design and technological characteristics of the Electric Wheelchair (JLE-W01A-2023) is similar to the predicates chosen. There are minor differences between the devices including Maximum safe operational incline degree, Armrest, Seat & Back cushion material, Braking distance, Battery charger, Overall Dimension, Folded Dimension, Wheel size/type, Max loading weight, Maximum distance of travel on the fully charged battery, Motor output and Turning Radius. All of the parameter with difference have been tested according to ISO7176 series standards and the test records support its safety and effectiveness. There is no deleterious effect on safety and effectiveness due to the minor differences do not influence the intended use of the device. Therefore, the proposed Wheelchair is substantially equivalent (SE) to The Power Wheelchair (K220747). 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 10993 series. | 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 and ISO10993-10 requirements. | S.E. | | EMC | ISO7176-21 & IEC 60601-1-2 | ISO7176-21 & IEC 60601-1-2 | S.E. | | Performance | ISO7176 series<br>IEC 62133-2 | ISO7176 series | S.E. | | Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. | Table 2 Safety comparison ### Table 3 Safety comparison | 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 | The Static stability has been determined<br>after the testing according to the ISO<br>7176-1, and test results meet its design | S.E. | | | specification. | specification. | | | 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. | | 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, | All test results meet the requirements<br>in Clause 7, 8, 9, 10, 11, 12, 13, 14, | S.E. | | | 15, 17 of ISO 7176-14. | 15, 17 of ISO 7176-14. | | | 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 16840-10 | 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. | | ISO 7176-25 | The Lead-acid batteries and chargers<br>results meet the requirements of ISO<br>7176-25. | The Lead-acid batteries and chargers<br>results meet the requirements of ISO<br>7176-25. | S.E. | {9}------------------------------------------------ ### Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China. {10}------------------------------------------------ ### Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China. ### I. Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Electric Wheelchair (JLE-W01A-2023), is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K220747.