(113 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.
The subject device, Power Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use.
The Power Wheelchair is a battery powered four wheeled vehicle. It consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.
The operation of the Controller: 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 wheelchair, the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. 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 change lever underneath the seat will allow for the brakes to engage or disengage. 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.
The Power Wheelchair has 7 inch front wheel and 12 inch rear tire.
Max. distance of travel on the fully charged battery is 7.5 km and Max. speed forward is 6.48 km/h.
When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate and friction plate to lock the motor, so as to brake.
The braking time is about 2s, and the braking distance is ≤1.5m.
Based on the provided FDA 510(k) clearance letter for the Vive Health LLC Power Wheelchair (MOB1107), here's an analysis addressing the acceptance criteria and study proving the device meets those criteria:
The document describes a Class II medical device (Powered Wheelchair, Product Code: ITI) undergoing a 510(k) premarket notification process. This process focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical efficacy or superiority through extensive clinical trials. Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to non-clinical performance testing against established international standards for wheelchairs, rather than AI/software performance metrics often seen in other medical device clearances.
Crucially, this document is for a physical medical device (power wheelchair), NOT a software/AI medical device. Many of the points you requested (e.g., number of experts, adjudication method, MRMC study, standalone AI performance, ground truth for training) are not applicable to this type of device clearance. The "performance" being evaluated here is mechanical, electrical, and safety performance of the wheelchair itself.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this power wheelchair are derived from international ISO standards for wheelchairs. The "reported device performance" is essentially a statement of compliance with these standards, indicating that various tests were conducted and the device met the specifications within those standards.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Aspect (Acceptance Criteria Reference Standard) | Reported Device Performance (Subject Device K250729) |
|---|---|
| Biocompatibility (Compliance with ISO 10993-5 and ISO 10993-10) | All directly tissue-contacting materials are identical to the Predicate Device, with Right-of-Reference from the predicate manufacturer, implying compliance. |
| Electromagnetic Compatibility (EMC) (ISO 7176-21 & IEC 60601-1-2) | The EMC performance results meet the requirements. |
| Static Stability (ISO 7176-1) | Determined after testing according to ISO 7176-1; test results meet design specification. |
| Dynamic Stability (ISO 7176-2) | Determined after testing according to ISO 7176-2; test results meet design specification. |
| Brake Effectiveness (ISO 7176-3) | Determined after testing according to ISO 7176-3; test results meet design specification. |
| Theoretical Distance Range (ISO 7176-4) | Determined after testing according to ISO 7176-4; test results meet design specification. |
| Dimensions & Mass (ISO 7176-5) | Determined after testing according to ISO 7176-5. |
| Dimensions & Mass (ISO 7176-6) | Determined after testing according to ISO 7176-6. |
| Seating & Wheel Dimensions (ISO 7176-7) | Determined after testing according to ISO 7176-7. |
| Static, Impact & Fatigue Strengths (ISO 7176-8) | All test results meet requirements in Clause 4 of ISO 7176-8. |
| Climatic Tests (Functionality after exposure) (ISO 7176-9) | Device continued to function according to manufacturer's specification after being subjected to tests specified in Clause 8 of ISO 7176-9. |
| Obstacle-climbing ability (ISO 7176-10) | Determined after testing according to ISO 7176-10. |
| Test Dummies suitability (ISO 7176-11) | Test dummies used meet the requirements of ISO 7176-11. |
| Coefficient of Friction of Test Surfaces (ISO 7176-13) | Determined, for use in other 7176 series tests. |
| Power and Control Systems (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 (ISO 7176-15) | Test results show information disclosure, documentation and labelling meet requirements. |
| Resistance to Ignition (ISO 16840-10) | Performance of resistance to ignition meets the requirements. |
| Performance Testing Set-up Procedures (ISO 7176-22) | ISO 7176-series performance testing used set-up procedures according to ISO 7176-22. |
| Batteries and Chargers Performance (ISO 7176-25) | Performance meets the requirements. |
| Maximum Braking Distance (Implicit in ISO 7176-3) | Reported as ≤0.9 m (Same as predicate, document states 2s braking time and ≤1.5m, but table says ≤0.9m). The document then clarifies "When you release the Joystick, the wheelchair is automatically braked. The braking time is about 2s, and the braking distance is ≤1.5m." The table comparison states "Braking distance ≤0.9m" and "Same" as predicate. This is a minor inconsistency in the summary but the acceptance is based on meeting the ISO 7176-3 design specification. |
| Maximum Safe Operational Incline Degree (Implicit in Dynamic Stability) | 10° (Same as predicate). |
| Maximum Speed Forward | 6.5 km/h (1.8 m/s) (Same as predicate). |
| Maximum Obstacle Climbing | 25 mm (Predicate was 40mm, so this is a difference, but likely still within an acceptable standard). |
Inapplicable/Not Provided Information for a Physical Wheelchair 510(k):
The following points are standard for AI/ML device submissions but are not applicable and therefore not provided in this traditional medical device 510(k) for a power wheelchair:
- Sample sizes used for the test set and the data provenance: Not relevant for physical device performance testing against engineering standards. The "samples" would be the manufactured wheelchairs tested. Data provenance typically refers to patient/clinical data, which isn't used for this type of device's "performance" evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance (e.g., brake effectiveness, stability) is established by physical measurement against engineering standards, not expert consensus on medical images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for human interpretation of data, typically medical images or clinical outcomes.
- 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 AI/software devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/software devices.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is defined by the technical specifications and testing methods outlined in the ISO 7176 series and IEC 60601-1-2 standards, confirmed by laboratory testing.
- The sample size for the training set: Not applicable. There is no AI/ML model for this device that requires training data.
- How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.
Summary of the "Study" Proving Substantial Equivalence and Meeting Criteria:
The "study" proving the Vive Health LLC Power Wheelchair (MOB1107) meets acceptance criteria and is substantially equivalent to its predicate device (K242791) is based entirely on non-clinical laboratory performance testing and technical comparisons.
- Study Design: The manufacturer performed a series of tests on the subject device according to the rigorous requirements of various international ISO 7176 series standards (for wheelchairs) and IEC 60601-1-2 (for electromagnetic compatibility/electrical safety).
- Measurement: These tests involve direct physical measurements of parameters like static stability, dynamic stability, brake effectiveness, theoretical distance range, dimensions, weight, maximum speed, obstacle-climbing ability, as well as evaluating material biocompatibility and electrical safety.
- Assessment of Compliance: The results of these tests were expected to "meet its design specification" or "meet the requirements" of the respective ISO standards. The submission asserts that the subject device's performance did meet these requirements.
- Substantial Equivalence Argument: The core of the 510(k) submission is that because the subject device demonstrates comparable technical characteristics and achieves equivalent performance (as verified by these standard tests) to a legally marketed predicate device, it is considered "substantially equivalent" in terms of safety and effectiveness. The document explicitly states: "All these tests have corresponding requirements/ acceptance criteria following above mentioned standards. And the test results show that the subject device is within acceptable performance specifications and thus substantially equivalent to the predicate device in performance."
- No Clinical Studies: The document explicitly states, "No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device." This reinforces that the safety and performance were established through non-clinical, engineering-based testing.
FDA 510(k) Clearance Letter - Power Wheelchair (MOB1107)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
July 2, 2025
Vive Health LLC
℅ Kiwi Xu
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Central Ave.
Shanghai, 200122
China
Re: K250729
Trade/Device Name: Power Wheelchair (MOB1107)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: May 22, 2025
Received: May 23, 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.
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K250729 - Kiwi Xu 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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K250729 - Kiwi Xu 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
Tushar Bansal, PhD
Acting 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K250729
Device Name
Power Wheelchair (MOB1107)
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)
☒ 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:
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FORM FDA 3881 (8/23) Page 1 of 1
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Vive Health LLC
8955 Fontana Del Sol Way, Naples, FL 34109, US
1 of 6
510k Summary
Submitter:
Name: Vive Health LLC
Address: 8955 Fontana Del Sol Way, Naples, FL 34109, US
Contact: Guy Savioli
Email: guy.savioli@igbrands.com
Prepared on: July 1, 2025
Device:
510(k) number: K250729
Device Trade Name: Power Wheelchair
Model: MOB1107
Classification name: Powered wheelchair
Regulation class: 2
Regulation number: 21CFR 890.3860
Panel: Physical Medicine
Product code: ITI
Predicate device:
510(k) number: K242791
Device Trade Name: Electric Wheelchair
Model: KR8807
Zhejiang Kairui Medical Device Co., Ltd.
Device description:
The subject device, Power Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use.
The Power Wheelchair is a battery powered four wheeled vehicle. It consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.
The operation of the Controller: 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 wheelchair, the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is
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Vive Health LLC
8955 Fontana Del Sol Way, Naples, FL 34109, US
2 of 6
automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric/ manual model change lever underneath the seat will allow for the brakes to engage or disengage. 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.
The Power Wheelchair has 7 inch front wheel and 12 inch rear tire.
Max. distance of travel on the fully charged battery is 7.5 km and Max. speed forward is 6.48 km/h.
When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate and friction plate to lock the motor, so as to brake.
The braking time is about 2s, and the braking distance is ≤1.5m.
Indication 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.
1. Product Parameters
Table 1 General Comparison
| Elements of Comparison | Subject Device (K250729) | Predicate Device (K242791) | Remark |
|---|---|---|---|
| Manufacturer | Vive Health LLC | Zhejiang Kairui Medical Device Co., Ltd. | - |
| Common or Usual name | Power Wheelchair | Power Wheelchair | Same |
| Model(s) | MOB1107 | KR-8807 | -- |
| 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. | 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. | Same |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 4, including two front wheels and two rear Wheels | 4, including two front wheels and two rear Wheels | Same |
| Function of wheels | Front wheels: driven wheels suitable for rotation, acceleration, retrograde. Rear wheels: driving wheels to control the speed and direction | Front wheels: driven wheels suitable for rotation, acceleration, retrograde. Rear wheels: driving wheels to control the speed and direction | Same |
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8955 Fontana Del Sol Way, Naples, FL 34109, US
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| Elements of Comparison | Subject Device (K250729) | Predicate Device (K242791) | Remark |
|---|---|---|---|
| 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 electronic brake system | Automatic electronic brake system | Same |
| Braking distance | ≤0.9 m | ≤0.9 m | Same |
| Maximum safe operational incline degree | 10 ° | 10 ° | Same |
| Armrest | PU | PU | Same |
| Battery charger | Off-board charger Input: 100-240V, 50/60Hz, 1.5A, Output: 24 Vdc, 2A; | Off-board charger Input: 100-240V, 50/60Hz, 1.5A, Output: 24 Vdc, 2A; | Same |
| Main frame material | Aluminum alloy | Aluminum alloy | Same |
| Seat cushion | Polyester fiber | Polyester fiber | Same |
| Back cushion | Polyester fiber | Polyester fiber | Same |
| Overall Dimension (lengthwidthheight) | 1000×620×900 mm | 1010×620×900 mm | Analysis: Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Folded Dimension (lengthwidthheight) | 790×360×730 mm | 780×350×730 mm | |
| Front wheel size/type | 7" x 1.3"/PU Solid tire | 7" x 1.3"/PU Solid tire | Same |
| Rear wheel size/type | 12" x 1.8"/PU Solid tire | 12" x 1.8"/PU Solid tire | Same |
| Max speed forward | 6.5 km/h(1.8 m/s) | 6.5 km/h(1.8 m/s) | Same |
| Max Speed backward | Less than 3.24 km/h (0.9m/s) | Less than 3.24 km/h (0.9m/s) | Same |
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8955 Fontana Del Sol Way, Naples, FL 34109, US
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| Elements of Comparison | Subject Device (K250729) | Predicate Device (K242791) | Remark |
|---|---|---|---|
| Max loading weight | 120 kg | 120 kg | Same |
| Battery | Lithium-ion battery; DC 25.2V 6Ah×1 | Lithium-ion battery; 25.9V 11.6Ah×1 | Analysis: The subject device complies with ISO 7176-4: 2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range, these differences do not affect safety and effectiveness. |
| Maximum distance of travel on the fully charged battery | 7.5 km | 15 km | |
| Motor | DC motor; 24VDC; 180W; 2200RPM | DC motor; 24VDC; 180W; 2200RPM | Same |
| Electronic controller | Brushless dual-drive rocker controller | Brushless dual-drive rocker controller | Same |
| Turning Radius | 887.5 mm | 900 mm | Analysis: The predicate device and subject device have different dimensions. Both comply with ISO 7176- 5:2008 and ISO 7176-10:2008, so these differences do not affect safety and effectiveness. |
| Maximum obstacle climbing | 25 mm | 40mm |
Table 2 Safety comparison
| Item | Subject Device | Predicate Device | Results |
|---|---|---|---|
| Biocompatibility | All directly tissue-contacting materials are identical to the Predicate Device, with Right-of-Reference from the predicate manufacturer. | All directly tissue-contacting materials are in compliance with ISO10993-5 and ISO10993-10 requirements. | Same |
| Electromagnetic Compatibility (EMC) | ISO7176-21 & IEC 60601-1-2 | ISO7176-21 & IEC 60601-1-2 | Same |
| Performance | ISO7176 series | ISO7176 series | Same |
| Label and labeling | Conforms to FDA Regulatory requirements | Conforms to FDA Regulatory requirements | Same |
| Item | Subject Device | Predicate Device | 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 |
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| Item | Subject Device | Predicate Device | Results |
|---|---|---|---|
| ISO7176-3 | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | Same |
| 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 dimensions, mass has been determined after the testing according to the ISO 7176-6 | The dimensions, mass has been determined after the testing according to the ISO 7176-6 | 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 test surfaces has been determined, which could be used in other 7176 series tests involved | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | Same |
| 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 |
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| Item | Subject Device | Predicate Device | Results |
|---|---|---|---|
| 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 |
| ISO 16840-10 | The performance of resistance to ignition meet the requirements of ISO 16840-10 | The performance of resistance to ignition meet the requirements of ISO 16840-10 | Same |
| ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | Same |
| ISO 7176-22 | The ISO 7176-series performance testing used set-up procedures according to ISO 7176-22 | The ISO 7176-series performance testing used set-up procedures according to ISO 7176-22 | Same |
| ISO 7176-25 | The performance of batteries and chargers for powered wheelchairs meet the requirements of ISO 7176-25 | The performance of batteries and chargers for powered wheelchairs meet the requirements of ISO 7176-25 | Same |
Substantial Equivalence Discussion
The proposed (subject) device and predicate device are complying to the same ISO standards, ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-7, ISO 7176-8, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 16840-10, ISO 7176-21, ISO 7176-22, ISO 7176-25, and 1995 FDA Guidance on 510(k) Submissions for Mechanical and Powered Wheelchairs. The subject device also provided electromagnetic compatibility (EMC) testing according to IEC 60601-1-2 and Enhanced-level software documentation (including verification and validation testing) in accordance with FDA's 2023 Guidance on the "Content of Premarket Submissions for Device Software Functions."
The proposed device performs in a similar manner to the predicate device. All these tests have corresponding requirements/ acceptance criteria following above mentioned standards. And the test results show that the subject device is within acceptable performance specifications and thus substantially equivalent to the predicate device in performance.
The performance testing demonstrates that the subject device is substantially equivalent to the predicate devices regarding Static ability (tipping angle), The Dynamic stability (Safe Gradient Maximum Gradient), Brake performance, Theoretical distance range, Dimension and weight, Maximum speed, Dimension of wheel Static, impact and fatigue strengths, Climatic tests, Obstacle-climbing ability, Dummy, friction of test surfaces, Power and control systems, Documentation and labeling, Resistance to ignition, Electromagnetic Compatibility and Electrical Safety, Batteries and chargers.
The non-clinical laboratory data support the safety and performance of the subject device and demonstrate that the subject device should perform as intended in the specified use conditions.
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Vive Health LLC
8955 Fontana Del Sol Way, Naples, FL 34109, US
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3. Summary of clinical testing:
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device.
4. Substantially Equivalency Conclusion
Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate devices, K242791 Power Wheelchair from Zhejiang Kairui Medical Device Co., Ltd.
§ 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).