Power Wheelchair (MOB1107)

K250729 · Vive Health, LLC · ITI · Jul 2, 2025 · Physical Medicine

Device Facts

• Record ID: K250729
• Device Name: Power Wheelchair (MOB1107)
• Applicant: Vive Health, LLC
• Product Code: ITI · Physical Medicine
• Decision Date: Jul 2, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Intended 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.

Device Story

Battery-powered four-wheeled vehicle; DC motor driven; user-operated via joystick controller. Input: user joystick movement (direction/speed). Transformation: controller processes joystick input to modulate motor speed/direction; solenoid brake engages automatically upon joystick release or power-off. Output: motorized mobility. Used in indoor/outdoor environments by disabled/elderly patients. Features quick assembly/disassembly for transport. Healthcare provider/user monitors speed via control panel; output provides independent mobility. Benefits: improved patient mobility and accessibility.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including static/dynamic stability, braking performance, obstacle climbing, EMC (IEC 60601-1-2), and electrical safety, all performed in accordance with ISO 7176 series standards.

Technological Characteristics

Aluminum alloy frame; PU solid tires; polyester fiber cushions. Powered by 24VDC 180W motor and Li-ion battery. Features brushless dual-drive rocker controller. Connectivity: off-board charger. Sterilization: N/A. Software: Enhanced-level documentation per 2023 FDA guidance. Standards: ISO 7176 series (stability, braking, dimensions, EMC, batteries), ISO 16840-10 (ignition resistance).

Indications for Use

Indicated for disabled or elderly persons limited to a seated position requiring indoor and outdoor mobility assistance.

Regulatory Classification

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.

Predicate Devices

• Electric Wheelchair (K242791)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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 (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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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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. |
| --- | --- |
| 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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "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." | |

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Vive Health LLC 8955 Fontana Del Sol Way, Naples, FL 34109, US

# 510k Summary

## Submitter:

Name: Vive Health LLC

Address: 8955 Fontana Del Sol Way, Naples, FL 34109, US

Contact: Guy Savioli

Email: [e-mail]

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

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 $7.5\mathrm{km}$ and Max. speed forward is $6.48\mathrm{km/h}$ . 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 $\leq 1.5\mathrm{m}$

## 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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Vive Health LLC
8955 Fontana Del Sol Way,Naples, FL 34109, US

| 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 (length*width*height) | 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 (length*width*height) | 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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Vive Health LLC 8955 Fontana Del Sol Way,Naples,FL 34109,US

| 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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Vive Health LLC
8955 Fontana Del Sol Way,Naples, FL 34109, US

| 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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Vive Health LLC
8955 Fontana Del Sol Way,Naples, FL 34109, US

| 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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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.

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