(183 days)
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.
This Electric Wheelchair, models: ME23-EW16-BC200-01.ME23-EW16-BC200-02, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box and charger. The device is powered by Li-ion Battery pack with 22 Km range, which can be recharged by an offboard battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
This is a 510(k) premarket notification for an Electric Wheelchair, a Class II medical device. The submission asserts substantial equivalence to a predicate device (K220747). The acceptance criteria for this device are established by adherence to various ISO 7176 series standards related to wheelchairs, as well as ISO 10993 for biocompatibility and IEC 60601-2-1 for EMC (which is also covered by ISO 7176-21).
Here's an analysis of the provided information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard/Test) | Reported Device Performance | Remark |
|---|---|---|
| Biocompatibility | ||
| ISO 10993-5: 2009 (In Vitro Cytotoxicity) | Compliance with requirements | S.E. |
| ISO 10993-10:2021 (Irritation And Skin Sensitization) | Compliance with requirements | S.E. |
| ISO 10993-23: 2021 (Irritation) | Compliance with requirements | S.E. |
| Electromagnetic Compatibility (EMC) | ||
| ISO 7176-21:2009 (EMC) | Performance results meet requirements | S.E. |
| IEC 60601-2-1 (EMC) | Performance results meet requirements | S.E. |
| Performance (ISO 7176 Series) | ||
| ISO 7176-1: 2014 (Static stability) | Test results meet design specification | S.E. |
| ISO 7176-2:2017 (Dynamic stability) | Test results meet design specification | S.E. |
| ISO 7176-3: 2012 (Effectiveness of brakes) | Test results meet design specification | S.E. |
| ISO 7176-4: 2008 (Energy consumption/theoretical distance range) | Test results meet design specification | S.E. |
| ISO 7176-5: 2008 (Overall dimensions, mass, maneuvering space) | Dimensions, mass determined | S.E. |
| ISO 7176-6: 2018 (Maximum speed, acceleration, deceleration) | Dimensions, mass determined | S.E. |
| ISO 7176-7 (Seating and wheel dimensions) | Seating and wheel dimensions determined | S.E. |
| ISO 7176-8:2014 (Static, impact and fatigue strengths) | All test results meet requirements in Clause 4 | S.E. |
| ISO 7176-9:2009 (Climatic tests) | Device continued to function per manufacturer's specification after tests | S.E. |
| ISO 7176-10:2008 (Obstacle-climbing ability) | Obstacle-climbing ability determined | S.E. |
| ISO 7176-11:2012 (Test dummies) | Test dummies used meet requirements | S.E. |
| ISO 7176-13: 1989 (Coefficient of friction of test surfaces) | Coefficient of friction determined | S.E. |
| ISO 7176-14:2008 (Power and control systems) | All test results meet requirements in Clauses 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 | S.E. |
| ISO 7176-15:1996 (Information disclosure, documentation & labeling) | Information disclosure, documentation and labeling meet requirements | S.E. |
| ISO 16840-10:2021 (Resistance to ignition of postural support devices) / ISO 7176-16 (Ignition resistance) | Performance meets requirements | S.E. |
| Labeling | ||
| FDA Regulatory | Conforms to FDA Regulatory | S.E. |
| Device-Specific Performance Metrics (Comparison with Predicate) | ||
| Braking distance | ≤ 1.9 m (Proposed) vs ≤ 1.5 m (Predicate) | Analysis (tested under ISO 7176-3) |
| Maximum safe operational incline degree | 10 ° (Proposed) vs 9 ° (Predicate) | S.E. |
| Overall Dimension (lengthwidthheight) | 11506701030mm (Proposed) vs 940610960mm (Predicate) | S.E. |
| Folded Dimension (lengthwidthheight) | 860670730mm (Proposed) vs 720310610mm (Predicate) | S.E. |
| Front wheel size/type | 7" x 2"/PU Solid tire (Proposed) vs 7" x 1.75"/PU Solid tire (Predicate) | S.E. |
| Rear wheel size/type | 10" x 2.5"/ PU solid tire (Proposed) vs 8.5" x 2"/ PU Solid tire (Predicate) | Analysis |
| Max speed forward | Up to 7.9 km/h (2.2 m/s), adjustable (Proposed) vs Up to 6 km/h (1.6 m/s), adjustable (Predicate) | Analysis (tested under ISO 7176-6) |
| Max Speed backward | Less than 3 km/h (0.5 m/s) (Proposed) vs Less than 3 km/h (0.5 m/s) (Predicate) | S.E. |
| Max loading weight | 125kg (Proposed) vs 136kg (Predicate) | Analysis (tested under ISO 7176-8) |
| Maximum distance of travel on the fully charged battery | 22 km (Proposed) vs 15 km (Predicate) | Analysis (tested under ISO 7176-4) |
| Motor | Brushless DC motor; 24VDC; 200W; 2pcs (Proposed) vs Brushless DC motor; 24VDC; 250W; 2pcs (Predicate) | S.E. |
| Turning Radius | 1100 mm (Proposed) vs 900 mm (Predicate) | Analysis |
| Maximum obstacle climbing | 10 mm (Proposed) vs 40 mm (Predicate) | Analysis (tested under ISO 7176-10) |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "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".
The "test set" in this context refers to the physical devices and materials undergoing the non-clinical performance and safety tests. The specific "sample size" (i.e., number of individual wheelchairs or components tested) for each standard is not provided in this summary.
The data provenance is from non-clinical tests conducted by the manufacturer, JiaXing XiaoXiang Medical Equipment Technology Co., Ltd., in China. The study is a retrospective comparison against established international standards and a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a non-clinical device that relies on adherence to engineering standards. No human experts were used to establish ground truth in the way they would for a diagnostic AI device (e.g., radiologists interpreting images). The "ground truth" for these tests is defined by the objective pass/fail criteria specified within each international standard (e.g., maximum braking distance, minimum static stability angle, etc.).
4. Adjudication method for the test set:
Not applicable. This is not a study requiring expert adjudication of results. The tests are objective measurements against pre-defined engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done. This device is an electric wheelchair, not an AI-powered diagnostic imaging tool or a device that assists human readers. No human-in-the-loop performance evaluation is relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The "device" in this context is the physical electric wheelchair. The non-clinical tests evaluate the standalone performance of the device against engineering standards, without human interaction influencing the test outcome itself (beyond operating the test equipment as per standard protocols). There is no "algorithm only" component in the sense of a software-as-a-medical-device.
7. The type of ground truth used:
The ground truth used for proving the device meets acceptance criteria is adherence to international consensus standards (ISO 10993 series, ISO 7176 series, IEC 60601-2-1) and comparison of technical specifications to a legally marketed predicate device. These standards define objective, measurable performance and safety requirements.
8. The sample size for the training set:
Not applicable. This is a hardware medical device; there is no "training set" in the context of an AI/machine learning algorithm. The closest analogy would be the engineering design and development process that led to the final product, but this is not reported as a "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no "training set" for an algorithm, there is no ground truth established in that sense. The device's design and manufacturing are based on established engineering principles and adherence to relevant international standards.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
October 29, 2024
JiaXing XiaoXiang Medical Equipment Technology Co., Ltd. % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, Shanghai 200122 China
Re: K241189
Trade/Device Name: Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: October 15, 2024 Received: October 15, 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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 Assistant Director, 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 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)
Device Name
Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02)
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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JiaXing XiaoXiang Medical Equipment Technology Co.,Ltd No.24-101,Lane 587,Taoyuan Road,Xiuzhou,Jiaxing,Zhejiang,China
510(k) Summary K241189
Document Prepared Date: 2024/4/28
Applicant: A. JiaXing XiaoXiang Medical Equipment Technology Co.,Ltd Address: No.24-101,Lane 587,Taoyuan Road,Xiuzhou, Jiaxing, Zhejiang, China
Contact Person: Jun Sun
Tel: +86-13755443131
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
Common Name: Powered wheelchair
Models: ME23-EW16-BC200-01, ME23-EW16-BC200-02
Regulatory Information
Classification Name: Powered wheelchair Classification: Class II Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine
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JiaXing XiaoXiang Medical Equipment Technology Co.,Ltd No.24-101,Lane 587,Taoyuan Road,Xiuzhou,Jiaxing,Zhejiang,China
C. Predicate device:
510(k) number: K220747 Classification Name: Powered wheelchair Regulation Number: 890.3860 Device Name: Power Wheelchair Model: N5515B Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
D. Indications for use of the device:
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
E. Device Description:
This Electric Wheelchair, models: ME23-EW16-BC200-01.ME23-EW16-BC200-02, is a motor driven,
indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitabled people with mobility difficulties and elderly people.
The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box and charger.
The device is powered by Li-ion Battery pack with 22 Km range, which can be recharged by an offboard battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.
The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic
electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
F. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
- ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And A Skin Sensitization
- ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for irritation A
- A ISO 7176-1: 2014, Wheelchairs - Part 1: Determination of static stability
- A ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of Powered Wheelchairs
- ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness ofbrakes V
- ISO 7176-4. Third edition 2008-10-01. Wheelchairs Part 4: Energy consumption of electric > wheelchairs and wheelchairs for determination of theoretical distance range
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- A ISO 7176-5, Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
- ♪ ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs
- A 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 ア fatigue strengths
-
ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for Powered Wheelchairs
- A 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
- ア 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 A 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 A Requirements and test methods
G. Clinical Test Conclusion
No clinical study is included in this submission.
H. Comparison with predicate Device
Table 1 General Comparison
| Elements ofComparison | Subject Device | Predicate Device (K220747) | Remark |
|---|---|---|---|
| Manufacturer | JiaXing XiaoXiang MedicalEquipment Technology Co.,Ltd | Zhejiang InnuovoRehabilitation Devices Co.,Ltd | - |
| Common or Usualname | Power Wheelchair | Power Wheelchair | Same |
| Model(s) | ME23-EW16-BC200-01,ME23-EW16-BC200-02 | N5515B | -- |
| Indications for use | It is a motor driven, indoor andoutdoor transportation vehicle withthe intended use to providemobility to a disabled or elderlyperson limited to a seated position. | It is a motor driven, indoor andoutdoor transportation vehiclewith the intended use to providemobility to a disabled or elderlyperson limited to a seatedposition. | S.E. |
| Use condition | indoor and outdoor use | indoor and outdoor use | S.E. |
| Number of wheels | 4,including two front wheels andtwo rear Wheels | 4,including two front wheelsand two rear Wheels | S.E |
| Function of wheels | Front wheels: driven wheelssuitable for rotation, acceleration,retrograde.Rear wheels: driving wheels tocontrol the speed and direction | Front wheels:drivenwheelssuitableforrotation,acceleration, retrograde.Rear wheels: driving wheels tocontrol the speed and direction | S.E |
| Movement controlmethod | By Joystick control | By Joystick control | S.E |
| Driving system | Direct drive on the rearwheels | Direct drive on the rearwheels | S.E |
| Brake system | Automatic electromagneticbrake system | Automatic electromagneticbrake system | S.E |
| Braking distance | ≤ 1.9 m | ≤ 1.5 m | Analysis |
| Maximum safeoperational inclinedegree | 10 ° | 9 ° | S.E |
| Armrest | PUR (polyurethane) | PU | S.E |
| Battery charger | Off-board chargerInput: 100-240V, 50/60Hz, 2.0A,Output: 29.4 Vdc, 2.8A; | Off-board chargerInput: 100-240V, 50/60Hz, 1.5A,Output: 24 Vdc, 2A; | S.E |
| Main frame material | Magnesium alloy | Carbon fiber material | Analysis |
| Back cushion | PUR (polyurethane) | Polyester fabric | Analysis |
| Seat cushion | PUR (polyurethane) | rubber patch cloth and Oxfordfabric | Analysis |
| Overall Dimension( length* width* height) | 11506701030mm | 940610960mm | S.E |
| Folded Dimension( length* width* height) | 860670730mm | 720310610mm | S.E |
| Front wheel size/type | 7" x 2"/PU Solid tire | 7" x 1.75"/PU Solid tire | S.E |
| Rear wheel size/type | 10" x 2.5"/ PU solid tire | 8.5" x 2"/ PU Solid tire | Analysis |
| Max speed forward | Up to 7.9 km/h (2.2 m/s),adjustable | Up to 6 km/h (1.6 m/s),adjustable | Analysis |
| 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 | 125kg | 136kg | Analysis |
| Battery | Li-ion battery pack; rechargeable,25.6 VDC 16Ah | Li-ion battery pack; rechargeable, 24 VDC 12Ah | Analysis |
| Maximum distance oftravel on the fullycharged battery | 22 km | 15 km | Analysis |
| Motor | Brushless DC motor; 24VDC;200W; 2pcs | Brushless DC motor; 24VDC;250W; 2pcs | S.E |
| Electronic controller | Brushless dual-drive rockercontroller | Brushless dual-drive rockercontroller | S.E |
| Turning Radius | 1100 mm | 900 mm | Analysis |
| Maximum obstacleclimbing | 10 mm | 40 mm | Analysis |
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JiaXing XiaoXiang Medical Equipment Technology Co.,Ltd No.24-101,Lane 587,Taoyuan Road,Xiuzhou,Jiaxing,Zhejiang,China
Difference analysis:
The design and technological characteristics of the Electric Wheelchair is similar to the predicates chosen. There are minor differences between the devices including Braking distance, Main frame material, Back & Seat cushion, Rear wheel size, Max speed forward, Max loading weight, Maximum distance of travel on the fully charged battery, Battery, Turning Radius and Maximum obstacle climbing. 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.
Table 2 Safety comparison
| 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 andISO10993-10 requirements. | S.E. |
| EMC | ISO7176-21 & IEC 60601-2-1 | ISO7176-21 | S.E. |
| Performance | ISO7176 series | ISO7176 series | S.E. |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. |
Table 3 Safety comparison
| Item | Proposed Device | Predicate Devices | Results |
|---|---|---|---|
| ISO7176-1 | The Static stability has been 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. |
| No.24-101, Lane 587, Taoyuan Road, Xiuzhou,Jiaxing,Zhejiang,China | |||
| 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. |
| 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 | |
| ISO7176-16/ISO 16840-10 | The performance of resistance toignition meet the requirements ofISO 16840-10 | The performance of resistance toignition meet the requirements ofISO 7176-16 | 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. |
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JiaXing XiaoXiang Medical Equipment Technology Co.,Ltd No.24-101,Lane 587,Taoyuan Road,Xiuzhou,Jiaxing,Zhejiang,China
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JiaXing XiaoXiang Medical Equipment Technology Co.,Ltd No.24-101,Lane 587,Taoyuan Road,Xiuzhou,Jiaxing,Zhejiang,China
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Power Wheelchair, Models: ME23-EW16-BC200-01, E23-EW16-BC200-02, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K220747.
§ 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).