(132 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 product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding, The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the wheelchair by the wheelchair by themselves through the control device.
The wheelchair uses lithium batteries as its power source. The drive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is carbon fiber. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels mover will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.
When in use, the operator drives the motor of the rear wheel by operating the controller handle (joystick) to achieve the rear wheels movement.
The DC Brushless motor and Brake system are fixed on the rear wheels. The max loading of the device is 125KG. Only for one person sit.
This is an FDA 510(k) premarket notification for an Electrically Powered Wheelchair (K241632).
For devices like this (powered wheelchairs), the acceptance criteria and study that proves the device meets them typically involve demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing to relevant international standards. Unlike AI/ML-based medical devices, there isn't a "test set" in the sense of a dataset for algorithm evaluation, nor are there "expert readers" establishing ground truth in the same way. The "performance" refers to the physical and functional aspects of the wheelchair.
Here's a breakdown based on the provided document:
Acceptance Criteria and Reported Device Performance
The document states that the device's acceptance criteria are met by demonstrating compliance with various international ISO and IEC standards relevant to electrically powered wheelchairs. The reported "performance" is inherently tied to passing these standards.
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance Status) |
|---|---|
| Mechanical & Performance Standards: | |
| ISO 7176-2:2001 (Wheelchair Testing - Mechanical Properties) | Complied |
| ISO 7176-3:2012 (Wheelchair Testing - Electrical Requirements) | Complied |
| ISO 7176-4:2008 (Wheelchair Testing - Climatic Requirements) | Complied |
| ISO 7176-5:2008 (Wheelchair Testing - Dimensions, Mass, and Maneuvering Space) | Complied |
| ISO 7176-6:2018 (Wheelchair Testing - Maximum Speed, Acceleration, Deceleration) | Complied |
| ISO 7176-7:1998 (Wheelchair Testing - Wheelchair Measurements) | Complied |
| ISO 7176-9:2009 (Wheelchair Testing - Climatic Chambers for Testing) | Complied |
| ISO 7176-10:2008 (Wheelchair Testing - Obstacle Climbing) | Complied |
| ISO 7176-11:2008 (Wheelchair Testing - Rolling Resistance) | Complied |
| ISO 7176-13:1989 (Wheelchair Testing - Static, Impact, and Fatigue Strengths) | Complied |
| ISO 7176-14:2008 (Wheelchair Testing - Power & Control Systems) | Complied |
| ISO 7176-15:1996 (Wheelchair Testing - Dimensions, Mass, and Volume) | Complied |
| ISO 7176-21:2014 (Wheelchair Testing - Electromagnetic Compatibility) | Complied |
| ISO 7176-22:2013 (Wheelchair Testing - Setup Procedures) | Complied |
| Material/Biocompatibility Standard: | |
| ISO 10993 series (Biological evaluation of medical devices) | Complied (for parts in contact with user) |
| Seating/Safety Standard: | |
| ISO 16840-10: 2021 (Wheelchair Seating - Flammability) | Complied (for seat cushion/backrest) |
| Electrical Safety/EMC Standard: | |
| IEC 60601-1-2: 2014 (Medical Electrical Equipment - EMC) | Complied |
| IEC 62133-2:2017 (Secondary Cells and Batteries - Safety) | Complied (for lithium battery) |
The document explicitly states: "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 K231508."
Study Details
Given the nature of the device (electrically powered wheelchair) and the information provided in the 510(k) summary, the "study" is a series of non-clinical, bench-top, and possibly simulated-use tests to demonstrate compliance with the referenced international standards.
-
Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size (e.g., number of wheelchairs tested). For non-clinical performance testing of physical devices, testing typically involves a representative sample or a single unit (depending on the test standard and design).
- Data Provenance: The document does not explicitly state the country of origin for the testing data itself. The applicant is Kunshan Hi-Fortune Health Products Co., Ltd in China, and their consultant is in Shanghai, China. It is highly probable that the testing was conducted in laboratories in China, often by accredited testing houses. The testing would be considered prospective in the sense that it was conducted specifically to demonstrate compliance for this 510(k) submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and 510(k) submission. "Ground truth" established by experts (like radiologists for AI algorithms) is not a component of demonstrating substantial equivalence for an electrically powered wheelchair. The "ground truth" here is the pass/fail criteria defined by the requirements of the international standards themselves. Compliance is verified by engineers and technicians performing the tests according to standard protocols.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation or clinical outcomes, typically in studies involving human readers or clinical trials. For non-clinical performance testing against engineering standards, compliance is objectively measured.
-
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:
- This is not applicable. MRMC studies are used to evaluate AI-assisted diagnostic devices in a clinical reading setting. This 510(k) is for a powered wheelchair, not a diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This refers to AI algorithm performance. This is not applicable as this is not an AI/ML device. The "standalone performance" refers to the physical functionality of the wheelchair according to the specified standards.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is objective compliance with the pass/fail criteria and specifications outlined in the referenced international standards (e.g., maximum speed, turning radius, battery performance, mechanical strength, electromagnetic compatibility limits, flammability). It is a standards-based performance evaluation, not clinical outcomes or expert interpretation.
-
The sample size for the training set:
- This is not applicable. There is no "training set" in the context of a physical device like a powered wheelchair unless it uses an AI/ML component (which is not described or implied here). The design and engineering of the wheelchair are based on established principles, not a data training set.
-
How the ground truth for the training set was established:
- This is not applicable for the same reasons as above.
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October 16, 2024
Kunshan Hi-Fortune Health Products Co., Ltd % Ariel Xiang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K241632
Trade/Device Name: Electrically powered wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 16, 2024 Received: September 16, 2024
Dear Ariel Xiang:
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
Electrically powered wheelchair
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)
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| 510(k) #: K241632 | 510(k) Summary | Prepared on: 2024-09-16 | |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Kunshan Hi-Fortune Health Products Co., Ltd | ||
| Applicant Address | NO.625 Juxiang Road, Zhangpu Town kunshan, Jiangsu, 215321 China | ||
| Applicant Contact Telephone | +86 13771986496 | ||
| Applicant Contact | Mr. Zhanli Tian | ||
| Applicant Contact Email | zhanli.tian@hi-fortune.net | ||
| Correspondent Name | Shanghai Sungo Management Consulting Co. Ltd. | ||
| Correspondent Address | 14th Floor, 1500# Century Avenue shanghai shanghai 200122 China | ||
| Correspondent Contact Telephone | +86-21-58817802 | ||
| Correspondent Contact | Ms. Ariel Xiang | ||
| Correspondent Contact Email | shouqiu.xiang@sungoglobal.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Electrically powered wheelchair | ||
| 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 | |
| K231508 | Power wheelchair, W5521 | ITI | |
| Device Description Summary | 21 CFR 807.92(a)(4) |
This product consists of frame, wheels, seat, armrest, ithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding, The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the wheelchair by the wheelchair by themselves through the control device.
The wheelchair uses lithium batteries as its power source. The crive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is carbon fiber. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels mover will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.
When in use, the operator drives the motor of the rear wheel by operating the controller handle (joystick) to achieve the rear wheels movement.
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The DC Brushiess motor and Brake system are fixed on the rear wheels. The max loading of the device is 125KG. Only for one person sit.
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
Same.
Technological Comparison
The subject device complied with the requirements of ISO 7176-2:2001, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008. ISO 7176-6:2018. ISO 7176-7:1998. ISO 7176-9:2009. ISO 7176-10:2008. ISO 7176-11:2008. ISO7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 16840-10: 2021, ISO7176-21:2014, ISO 7176-22:2013, IEC 60601-1-2: 2014, IEC 62133-2:2017.
The intended uses for both devices are the same. Mainframes of two devices are folded by way of front and rear close.
The design principles of the controller and Driving system are the requirements of the ISO 7176-14.2008. Software validation is carried out on both control systems and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012.
Turning radius and Maximum obstacle climbing are sightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the ISO 7176-22001, ISO 7176-10:2008.
The flame retardant test of the seat cushion/backrest of the subject device is conducted according to ISO 16840-10. Therefore, both devices are assured to be under the same safety level.
The all rest different between the subject device can proved the safety or effectiveness by the ISO 7176 series support reports.
Different material used for parts in contact with user, which such differences will not impact the subject device as biocompatibility tests are carried out according to ISO 10993 series.
In conclusion, the technological characteristics, features, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject devices do not raise new issues of safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Not Applicable
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 K231508.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
§ 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).