(68 days)
Not Found
No
The description details a standard power wheelchair with joystick control and basic speed adjustments. There is no mention of AI, ML, or any features that would suggest autonomous navigation, predictive control, or learning capabilities. The performance studies focus on compliance with established standards for power wheelchairs, not on AI/ML performance metrics.
Yes
The device is intended to provide mobility to disabled or elderly persons, which is a therapeutic purpose.
No.
The device is described as a transportation vehicle to provide mobility, not to diagnose medical conditions or diseases.
No
The device description clearly outlines numerous hardware components including a motor, battery, wheels, joystick controller, and various physical parts of a wheelchair. It is a physical device with integrated software for control, not a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to a disabled or elderly person. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a transportation vehicle with components like a motor, battery, wheels, and controls. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological material. There is no mention of diagnostic assays, reagents, or laboratory procedures.
The device is clearly described as a power wheelchair, which is a medical device used for mobility assistance, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The subject device, Power Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. The power wheelchair is a battery powered four wheel t consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick control panel(including: Battery indicate, ON/OFF button, Horn, Gear indicator, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheels. The operation of the scooter: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will deternine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the wheelchair uns. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric / manual model the seat will allow for the brakes to engage. When adjusted to the manual model, the assistant can easily push the wheelchair. The power wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to verify that the proposed device met all design specifications for Substantially Equivalent (SE) comparison to the predicate device. The test results demonstrated that the proposed device camplies with the following standards:
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 for determination of theoretical distance range
ISO 7176-5, Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space
ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs
ISO 7176-7, Wheelchairs - Part 7: Measurement of seating and wheel dimensions
ISO 7176-8:2014,Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for Powered Wheelchairs
ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies.
ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered 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 devicesRequirements and test method.
ISO 7176-19:2022 Wheelchairs Part 19: Wheelchairs for use as seats in motor vehicles
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
No clinical test data was submitted.
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Power Wheelchair, model: YH-E6011 YH-E6013A, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K240638.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
March 26, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
Ningbo Youhuan Automation Technology Co., Ltd. % Kiwi Xu Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, 200122 China
Re: K250134
Trade/Device Name: Power Wheelchair (YH-E6011,YH-E6013A) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 17, 2025 Received: January 17, 2025
Dear Kiwi Xu:
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.
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 Rue"). 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-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-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).
2
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
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
| Power Wheelchair (YH-E6011,YH-E6013A) |
|---|
| --------------------------------------- |
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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4
| 510(k) #: | 510(k) Summary | Prepared on: 2025-03-17 | ||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Ningbo Youhuan Automation Technology Co.,Ltd. | |||
| Applicant Address | Room 103-24, No. 352, No. 277 Shui Street, No. 756 Tiantong South Road, Yinzhou District, Ningbo City, Zhejiang Province, CN Ningbo 315000 China | |||
| Applicant Contact Telephone | +86 13186861505 | |||
| Applicant Contact | Mr. Xu Francis | |||
| Applicant Contact Email | francis@nbyouhuan.com | |||
| Correspondent Name | Shanghai SUNGO Management Consulting Co., Ltd. | |||
| Correspondent Address | 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai 200122 China | |||
| Correspondent Contact Telephone | +86 17863803443 | |||
| Correspondent Contact | Ms. Kiwi Xu | |||
| Correspondent Contact Email | weijia.xu@sungoglobal.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Power Wheelchair (YH-E6011,YH-E6013A) | |||
| Common Name | Powered wheelchair | |||
| Classification Name | Wheelchair, Powered | |||
| Regulation Number | 890.3860 | |||
| Product Code(s) | ITI | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K240638 | Power Wheelchair | ITI | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| The subject device, Power Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. |
The power wheelchair is a battery powered four wheel t consists Li-ion battery with an off-board battery charger, Push
handle, Seat, Back support, Joystick control panel(including: Battery indicate, ON/OFF button, Horn, Gear indicator,
Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheels.
The operation of the scooter: Use the On/Off button to turn on or turn off the power,
The main function of the Joystick is to control the speed and direction of the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will deternine the wheelchair in that direction speed of movement. The farther
5
the Joystick is moving from the center, the wheelchair uns. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric / manual model the seat will allow for the brakes to engage. When adjusted to the manual model, the assistant can easily push the wheelchair. The power wheelchair has a structure for quick assembly and
disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.
Intended Use/Indications for Use
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.
Indications for Use Comparison
Indication for Use statements are the same between the predicate and subject device.
Technological Comparison
The design and technological characteristics of the Power Wheelchair is similar to the predicates chosen. There are minor differences between the devices including Maximum safe operational incline degree, Main frame material, Armrest, Seat cushion, Rear wheel size/ type, Max speed forward, Max loading weight, Maximum distance of travel battery, Turning Radius and Maximum obstacle climbing. All of the parameter with difference have been tested according to ISO 7176 series standards and the test records support its safety and effectiveness. There is no deleterious effectiveness due to the minor differences do not influence the intended use of the device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical tests were conducted to verify that the proposed device met all design specifications for Substantially Equivalent (SE) comparison to the predicate device. The test results demonstrated that the proposed device camplies with the following standards:
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 for determination of theoretical distance range ISO 7176-5, Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs ISO 7176-7, Wheelchairs - Part 7: Measurement of seating and wheel dimensions ISO 7176-8:2014,Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for Powered Wheelchairs ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies. ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered 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 devicesRequirements and test method. ISO 7176-19:2022 Wheelchairs Part 19: Wheelchairs for use as seats in motor vehicles 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 No clinical test data was submitted.
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Power Wheelchair, model: YH-E6011 YH-E6013A, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K240638.
21 CFR 807.92(a)(6)
21 CFR 807 92(a)(5)
21 CFR 807 92(a)(5)