(57 days)
This Electric Wheelchair 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.
The product is intended only carry one person and used as a means of transportation for the disabled, and sick.
The electric wheelchair is classified as class B and the maximum occupant mass is 120kg.
The Electric Wheelchair is a battery powered four wheeled vehicle.
It consists two Lithium batteries with an off-board battery charger, frame, controller, motors, seat with cushion, back support with cushion, control device (including the battery power indicator, power ON button, power OFF button, horn button, speed indicator, speed-up button, slow-l down button, joystick, charging port), arm supports, two rear wheels, two casters(front wheels), foot support, anti-tip devices, push handle.
The wheelchair can easily fold and unfold for transportation or storage.
The provided FDA 510(k) clearance letter for the Electric Wheelchair (F309) does not describe a study involving AI or human-in-the-loop performance measurement. This document pertains to a physical medical device (an electric wheelchair) and focuses on demonstrating its substantial equivalence to a predicate device through non-clinical performance and safety testing against established ISO standards.
Therefore, many of the requested points regarding acceptance criteria and study design for AI/human-in-the-loop performance cannot be extracted from this document, as they are not relevant to the clearance of this type of device.
However, I can extract information related to the non-clinical tests that were conducted to prove the device meets its design specifications and safety requirements.
Here's a breakdown based on the provided document, addressing the extractable information:
Acceptance Criteria and Device Performance for Electric Wheelchair (F309)
The acceptance criteria for the Electric Wheelchair (F309) are based on demonstrating compliance with a comprehensive set of ISO 7176 series standards for wheelchairs, as well as biocompatibility and electromagnetic compatibility (EMC) standards. The device performance is deemed acceptable if it meets the requirements outlined in these standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and that "The test results demonstrated that the proposed device complies with the following standards." For each standard, the acceptance criterion is implicitly "meets the requirements of the standard," and the reported performance is that the device did meet those requirements.
Note: Specific quantitative thresholds for "acceptance criteria" are generally detailed within the referenced ISO standards themselves, not typically in a 510(k) summary (unless there's a deviation or specific performance claim being made). The document generally confirms compliance.
| Acceptance Criteria (Based on Compliance with Standard) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Biocompatibility: Device materials in direct user contact comply with ISO 10993-1. | "All user directly contacting materials are compliance with ISO10993-1" |
| EMC: Device complies with ISO 7176-21, IEC 60601-1-2:2014+A1:2020, and IEC TR 60601-4-2:2016. | "The EMC performance results meet the requirements of ISO 7176-21, IEC 60601-1-2:2014+A1:2020 and IEC TR 60601-4-2:2016." |
| Static Stability: Determined according to ISO 7176-1. | "The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification." |
| Dynamic Stability: Determined according to ISO 7176-2. | "The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification." |
| Brake Effectiveness: Determined according to ISO 7176-3. | "The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification." |
| Theoretical Distance Range: Determined according to ISO 7176-4. | "The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification." |
| Overall Dimensions, Mass, & Maneuvering Space: Determined according to ISO 7176-5. | "The dimensions, mass has been determined after the testing according to the ISO 7176-5." |
| Maximum Speed, Acceleration, & Deceleration: Determined according to ISO 7176-6. | "The maximum speed, acceleration and deceleration has been determined after the testing according to the ISO 7176-6." |
| Seating & Wheel Dimensions: Determined according to ISO 7176-7. | "The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7." |
| Static, Impact & Fatigue Strengths: Meets requirements in Clause 4 of ISO 7176-8. | "All test results meet the requirements in Clause 4 of ISO 7176-8." |
| Climatic Tests: Continues to function after tests in 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." |
| Obstacle-climbing ability: Determined according to ISO 7176-10. | "The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10." |
| Test Dummies: Meet requirements of ISO 7176-11 (for other tests). | "The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11." |
| Coefficient of Friction of Test Surfaces: Determined according to ISO 7176-13. | "The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved." |
| Power & Control Systems: Meet 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." |
| Information Disclosure, Documentation & Labeling: Meet requirements of ISO 7176-15. | "The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15." |
| Resistance to Ignition: Meets requirements of ISO 7176-16. | "The performance of resistance to ignition meet the requirements of ISO 7176-16." |
| Batteries & Chargers: Meet 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." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of devices. For physical device testing against standards, it's typically one or a few representative units of the device that undergo the specified tests. The document implies that the "proposed device" (singular) was tested.
- Data Provenance: The tests are non-clinical (laboratory/engineering tests) performed to verify design specifications. The company, Changshu Pingfang Wheelchair Co., Ltd, is located in China. The tests would have been performed by or on behalf of the manufacturer, likely at a certified testing facility. The data is prospective in the sense that it's generated specifically for this submission to verify safety and performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For non-clinical device performance testing against ISO standards, "ground truth" is established by the test methodology and the physical properties of the device as measured by calibrated equipment and verified according to the standard protocols. There are no human experts establishing a "ground truth" in the clinical sense (e.g., radiologists interpreting images).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human interpretation or adjudication. The assessment is based on objective measurements against 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
Not applicable. This is for an electric wheelchair, not an AI-assisted diagnostic or therapeutic device. No human reader study (MRMC) was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm for standalone performance evaluation in the medical imaging sense. Its performance is physical and mechanical.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device is the adherence to the requirements and specifications outlined in the referenced international standards (primarily ISO 7176 series, ISO 10993-1, IEC 60601 series). This is verified through physical and electrical measurements and tests conducted in a laboratory setting. It is a technical/engineering standard conformance ground truth, not a clinical ground truth.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
FDA 510(k) Clearance Letter - Electric Wheelchair (F309)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 9, 2025
Changshu Pingfang Wheelchair Co., Ltd
℅ Luna Hu
Official Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave
Shanghai, 200122
China
Re: K250758
Trade/Device Name: Electric Wheelchair (F309)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: March 13, 2025
Received: March 13, 2025
Dear Luna Hu:
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.
Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
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,
Tushar Bansal -S
for Heather Dean, PhD
Assistant Director, Acute Injury Devices Team
DHT5B: Division of Neuromodulation and
Physical Medicine Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K250758
Device Name: Electric Wheelchair (F309)
Indications for Use (Describe)
This Electric Wheelchair 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)
☑ 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
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"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."
Page 5
510(k) Summary
Document Prepared Date: 2025/03/13
1. Applicant
Company name: CHANGSHU PINGFANG WHEELCHAIR CO., LTD
Address: No.3 Ziqiang Road, Shanghu Town, Changshu Suzhou City, Jiangsu Province, China
Contact Person: Mr. Zhu Jian
Tel: 86-18936107511
Submission Correspondent:
Primary Contact: Luna Hu
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China
Tel: 0086-21-58817802
Email: liu.hu@sungoglobal.com
Secondary Contact: Raymond Luo
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China
Tel: 0086-21-68828050
Email: zxfda@sungoglobal.com
2. Device
Trade name: Electric Wheelchair (F309)
Classification name: Powered wheelchair
Model: F309
Regulatory Information
Classification: Class II
Product code: ITI
Regulation Number: 890.3860
Review Panel: Physical Medicine
3. Predicate Device
Manufacturer: NANJING E-TAKE MEDICAL APPARATUS CO., LTD.
Product Name: Electric Wheelchair (MODEL H)
510(K) #: K242989
Page 6
4. Indication for Use
This Electric Wheelchair 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.
5. Device Description
The product is intended only carry one person and used as a means of transportation for the disabled, and sick.
The electric wheelchair is classified as class B and the maximum occupant mass is 120kg.
The Electric Wheelchair is a battery powered four wheeled vehicle.
It consists two Lithium batteries with an off-board battery charger, frame, controller, motors, seat with cushion, back support with cushion, control device (including the battery power indicator, power ON button, power OFF button, horn button, speed indicator, speed-up button, slow-l down button, joystick, charging port), arm supports, two rear wheels, two casters(front wheels), foot support, anti-tip devices, push handle.
The wheelchair can easily fold and unfold for transportation or storage.
6. 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 10993-1: 2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- ISO 7176-1:2014, Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
- ISO 7176-3:2012, Wheelchairs - Part 3: Determination of effectiveness of brakes
- ISO 7176-4:2008, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- ISO 7176-5:2008, 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 electrically 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 electric wheelchairs
Page 7
- 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 7176-13:1989, 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 scooters - Requirements and test methods
- ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
- ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
- 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 scooters, and battery chargers
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
7. Clinical Test Conclusion
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electric wheelchair to its predicate device.
8. Comparison technological characteristics with the predicate device
Table 1 General Comparison
| Elements of Comparison | Subject Device (K250758) | Predicate Device (K242989) | Remark |
|---|---|---|---|
| Manufacturer | CHANGSHU PINGFANG WHEELCHAIR CO., LTD | NANJING E-TAKE MEDICAL APPARATUS CO., LTD | -- |
| Device name | Electric Wheelchair | Electric Wheelchair | -- |
| Model(s) | F309 | MODEL H | -- |
| Indication for use | The Electric wheelchair 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. | The Electric wheelchair 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. | Same |
| Intended user | disabled or elderly person limited to a seated position | disabled or elderly person limited to a seated position | Same |
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| Use condition | Indoor and outdoor use | Indoor and outdoor use | Same |
|---|---|---|---|
| Number of wheels | 6, including two front wheels and two rear wheels, two anti-tip wheels | 6, including two front wheels and two rear wheels, two anti-tip wheels | Same |
| Function of wheels | Front wheels: driven wheels suitable for rotation, acceleration, retrogradeRear wheels: driving wheels to control the speed and directionAnti-tip wheels: preventing the wheelchair from tipping turning over when driving on the slope.Non-adjustable | Front wheels: driven wheels suitable for rotation, acceleration, retrogradeRear wheels: driving wheels to control the speed and directionAnti-tip wheels: preventing the wheelchair from tipping turning over when driving on the slope.Non-adjustable | Same |
| Movement control method | By joystick control | By joystick control | Same |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Brake system | Automatic electromagnetic brake system | Automatic electromagnetic brake system | Same |
| Battery charger | Off-board chargerInput: 100-240VAC, 50/60Hz, 1.5AOutput: 24VDC, 2.0A; | Off-board chargerInput: 100-240VAC, 50-60Hz 1.2-0.5AOutput: 24 Vdc, 2A; | Similar |
| Max Loading(on level ground) | 120KG | 120KG | Same |
| Max obstacle climbing | 20mm | 25mm | Different |
| Total mass | 26KG | 23KG | Different |
| Overall dimension (mm) | 970590890 | 1130660950 | Different |
| Stowage Dimension (mm) | 720410600 | 890360900 | Different |
| Front wheel | 7inch/Solid tires | 7inch/Solid tires | Same |
| Rear wheel | 8inch/Solid tires | 24inch/Solid tires | Different |
| Max Speed (forward) | 6.48km/h(1.8m/s) | 6.84km/h(1.9m/s) | Different |
| Max Speed (backward) | 3.24km/h(0.9m/s) | 3.24km/h(0.9m/s) | Same |
| Maximum safe operational incline degree | 6° | 6° | Same |
| Brake Distance-Normal operation (Horizontal-Forward-Max speed) | 1.0m | 1.1m | Similar |
| Battery | Lithium-ion battery; Rechargeable, 24V, 9.09Ah, | Lithium-ion battery; Rechargeable, 24V 10Ah | Similar |
Page 9
| 218Wh | |||
|---|---|---|---|
| Maximum distance of travel on the fully charged battery | 20km | 8.2km | Different |
| Motor | Brushless DC motor; 24VDC 180W*2 | Brushless DC motor; 24VDC 200W*2 | Similar |
| Electronic controller | WS-24V | Micon CON7084-WB controller | Different |
| Turn Radius | 1000mm | 925mm | Similar |
Difference analysis
The design and technological characteristics of the proposed Electric Wheelchair is similar to the predicate device. There are minor differences between the devices in max obstacle climbing, size, weight, rear wheel size, max speed (forward), brake distance, turn radius, motor output, travel distance and controller model. All of the parameters with differences 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 Electric Wheelchair is substantially equivalent (SE) to The Electric Wheelchair (K242989).
Table 2 safety comparison
| Item | Subject Device | Predicate Device (K242989) | Results |
|---|---|---|---|
| Biocompatibility | All user directly contacting materials are compliance with ISO10993-1 | All user directly contacting materials are compliance with ISO10993-1 | Same |
| EMC | ISO7176-21& IEC 60601-1-2:2014+A1:2020 &IEC TR 60601-4-2:2016 | ISO7176-21& IEC 60601-1-2:2014+A1:2020 | Same |
| Performance | ISO7176 series | ISO7176 series | Same |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | Same |
| Item | Subject Device | Predicate Device (K242989) | Results |
|---|---|---|---|
| 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. | Same |
| 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. | Same |
| ISO7176-3 | The effectiveness of brakes has been determined after | The effectiveness of brakes has been determined after | Same |
Page 10
| the testing according to the ISO 7176-3, and test results meet its design specification. | the testing according to the ISO 7176-3, and test results meet its design specification. | ||
|---|---|---|---|
| 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. | Same |
| 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. | Same |
| ISO7176-6 | The maximum speed, acceleration and deceleration has been determined after the testing according to the ISO 7176-6. | The maximum speed, acceleration and deceleration has been determined after the testing according to the ISO 7176-6. | Same |
| 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. | Same |
| 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. | Same |
| 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. | Same |
| 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. | Same |
| 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. | Same |
| ISO7176-13 | The coefficient of friction of | The coefficient of friction | Same |
Page 11
| test surfaces has been determined, which could be used in other 7176 series tests involved. | of test surfaces has been determined, which could be used in other 7176 series tests involved. | ||
|---|---|---|---|
| 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. | Same |
| ISO7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15. | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15. | Same |
| ISO7176-16 | The performance of resistance to ignition meet the requirements of ISO 7176-16. | The performance of resistance to ignition meet the requirements of ISO 7176-16. | Same |
| ISO7176-21 | The EMC performance results meet the requirements of ISO 7176-21, IEC 60601-1-2:2014+A1:2020 and IEC TR 60601-4-2:2016. | The EMC performance results meet the requirements of ISO 7176-21, IEC 60601-1-2:2014+A1:2020. | Same |
| 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. | Same |
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K242989.
§ 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).