(57 days)
Not Found
No
The provided text describes a standard electric wheelchair with basic mechanical parts and controls. There is no mention of AI, DNN, ML, or any image processing, which are common indicators of AI models in medical devices.
Yes
The device, an electric wheelchair, is designed to provide mobility to individuals who are disabled or elderly and limited to a seated position, which directly addresses a health-related need or condition.
No
The device is an electric wheelchair used for transportation and mobility, not for diagnosis of any condition. Its purpose is to assist a person with movement, not to provide information about the presence, absence, or nature of a disease or condition.
No
The device description clearly details numerous hardware components including motors, batteries, frame, wheels, and a physical control device (joystick, buttons). The performance studies describe testing related to the physical properties and performance of the wheelchair. There is no mention of this being a software-only device.
No
The device is an electric wheelchair intended for transportation, not for in vitro examination of specimens from the human body.
N/A
Intended Use / Indications 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.
Product codes
ITI
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.
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
disabled or elderly person limited to a seated position / Indoor and outdoor use
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
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, ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-25:2013, ISO 16840-10: 2021, ISO 7176-21:2009, IEC 60601-1-2:2014+A1:2020. 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.
Key Metrics
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).
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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.
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K250758 - Luna Hu 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-
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K250758 - Luna Hu 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)
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
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."
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, retrograde | ||
| Rear wheels: driving wheels to control the speed and direction | |||
| Anti-tip wheels: preventing the wheelchair from tipping turning over when driving on the slope. | |||
| Non-adjustable | Front wheels: driven wheels suitable for rotation, acceleration, retrograde | ||
| Rear wheels: driving wheels to control the speed and direction | |||
| Anti-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 charger | ||
| Input: 100-240VAC, 50/60Hz, 1.5A | |||
| Output: 24VDC, 2.0A; | Off-board charger | ||
| Input: 100-240VAC, 50-60Hz 1.2-0.5A | |||
| Output: 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 |
| Motor | Brushless DC motor; 24VDC 180W*2 | Brushless DC motor; 24VDC 200W*2 |
| Electronic controller | WS-24V | Micon CON7084-WB controller |
| Turn Radius | 1000mm | 925mm |
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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| ISO7176-13 | The coefficient of friction of | The coefficient of friction |
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. |
| 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. |
| 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. |
| 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. |
| 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. |
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.