← Product Code [INI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI) · K253936

# Power Mobility Scooter (MJMA01, MJMA02) (K253936)

_Nanjing Mijo Technology Co., Ltd. · INI · Mar 12, 2026 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K253936

## Device Facts

- **Applicant:** Nanjing Mijo Technology Co., Ltd.
- **Product Code:** [INI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI.md)
- **Decision Date:** Mar 12, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3800
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## 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.

## Device Story

Battery-powered four-wheeled mobility scooter; provides mobility to disabled or elderly persons in seated position. User operates via control device (throttle, brake, handlebars, speed adjustment). Includes frame, motor, seat, back support, foot pedal, anti-tip devices. MJMA02 includes armrests; MJMA01 does not. Used indoors and on paved outdoor surfaces. Provides independent mobility; enhances quality of life for users with limited mobility.

## Clinical Evidence

No clinical data or animal studies provided. Substantial equivalence demonstrated through bench testing per ISO 7176 series and biocompatibility standards.

## Technological Characteristics

Four-wheeled scooter; aluminum alloy frame; 24V 250W motor; Li-ion battery (24V 5.8Ah*2). Electromagnetic braking system. Dimensions: 1000 x 600 x 900 mm. Max load 120kg. Complies with ISO 7176 series (stability, braking, energy, dimensions, strength, climatic, obstacle-climbing, EMC). Biocompatibility per ISO 10993.

## Regulatory Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

## Predicate Devices

- Mobility Scooter (W3431D) ([K231428](/device/K231428.md))

## Submission Summary (Full Text)

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>
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FDA U.S. FOOD & DRUG ADMINISTRATION

March 12, 2026

Nanjing Mijo Technology Co., Ltd.
% Luna Hu
Primary Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai, 200122
China

Re: K253936
Trade/Device Name: Power Mobility Scooter (MJMA01, MJMA02)
Regulation Number: 21 CFR 890.3800
Regulation Name: Motorized Three-Wheeled Vehicle
Regulatory Class: Class II
Product Code: INI
Dated: December 9, 2025
Received: December 9, 2025

Dear Luna Hu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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"

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

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K253936 - Luna Hu
Page 2

(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the Medical Device File (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 Management System Regulation (QMSR) (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-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).

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K253936 - Luna Hu
Page 3

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

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Power Mobility Scooter
Page 12 of 40

|  Indications for Use  |   |   |
| --- | --- | --- |
|  Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K253936 | ?  |
|  Please provide the device trade name(s). |  | ?  |
|  Power Mobility Scooter (MJMA01, MJMA02) |  |   |
|  Please provide your Indications for Use below. |  | ?  |
|  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. |  |   |
|  Please select the types of uses (select one or both, as
applicable). | ☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ?  |

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510(k) Summary

Document Prepared Date: 2025/12/8

1. Applicant

Company name: Nanjing Mijo Technology Co., Ltd.
Address: 2nd Floor, Building A3, Hongfeng Science and Technology Park, No. 3 Zhixin Road, Nanjing Economic and Technological Development Zone 210000 Nanjing, Jiangsu Province, China
Contact Person: Mr. Leo Zhang
Tel: +8618061882533

Submission Correspondent:

Primary Contact: Luna Hu
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China
Tel: 0086-21-58817802
Email: liu.hu@sungoglobal.com
Secondary Contact: Raymond Luo
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China
Tel: 0086-21-68828050
Email: zxfda@sungoglobal.com

2. Device

Trade name: Power Mobility Scooter (MJMA01, MJMA02)
Classification name: Motorized three-wheeled vehicle

Regulatory Information

Classification: Class II
Product code: INI
Regulation Number: 890.3800
Review Panel: Physical Medicine

3. Predicate Device

Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Product Name: Mobility Scooter (W3431D)
510(K) #: K231428

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4. 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.

5. Device Description

The sample is a Mobility Scooter which provides mobility to a disabled or elderly person limited to a seated position.

This product is primarily for indoor use and the outdoor.

The Mobility Scooter is classified in the Class B and the maximum loading weight is 120kg.

The scooter is a battery powered four wheeled vehicle.

It consists one Lithium-ion battery with an off-board battery charger, frame, controllers, motors, seat, back support, control device (including power switch & speed adjustment, horn switch, throttle & brake, handlebars, head lamp switch, real-time speed, power), two rear wheels, two front wheels, foot support(pedal), anti-tip devices.

For convenience of transportation and reduction of possible damage, the battery can be dismantled and separately packaged.

Users can also easily assemble these parts without use of the tools.

MJMA01 is not equipped with armrests, while MJMA02 is equipped with armrests. That is the only difference between the 2 models.

6. Non-clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2021 Biological Evaluation of Medical Devices -- Part 10: Tests For Skin Sensitization
- ISO 10993-23:2021 Biological Evaluation of Medical Devices -- Part 23: Test for Intracutaneous Reactivity
- ISO 7176-1:2014, Wheelchairs - Part 1: Determination of static stability
- ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs
- ISO 7176-3:2012, Wheelchairs - Part 3: Determination of effectiveness of brakes
- ISO 7176-4:2008, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- ISO 7176-5:2008, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space

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> ISO 7176-6:2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs
> ISO 7176-7:1998, Wheelchairs - Part 7: Measurement of seating and wheel dimensions
> ISO 7176-8:2014, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
> ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for electric wheelchairs
> ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
> ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies
> ISO 7176-13:1989, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
> ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
> ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
> ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
> ISO 16840-10: 2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
> ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
> IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

## 7. Clinical Test Conclusion

No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electric wheelchair to its predicate device.

## 8. Comparison technological characteristics with the predicate device

Table 1 General Comparison

|  Elements of Comparison | Subject Device (K253936) | Predicate Device (K231428) | Remark  |
| --- | --- | --- | --- |
|  Manufacturer | Nanjing Mijo Technology Co., Ltd. | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. | --  |
|  Device name | Power Mobility Scooter | Mobility Scooter | --  |
|  Model(s) | MJMA01
MJMA02 | W3431D | --  |
|  Indication for use | It is a motor driven, indoor and outdoor transportation vehicle | It is a motor driven, indoor and outdoor transportation vehicle | Same  |

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Nanjing Mijo Technology Co., Ltd.

|   | with the intended use to provide mobility to a disabled or elderly person limited to a seated position | with the intended use to provide mobility to a disabled or elderly person limited to a seated position. |   |
| --- | --- | --- | --- |
|  Overall dimension (mm) | 1000 x 600 x 900 | 1020 x 500 x 840 | Similar  |
|  Frame Material | Aluminium alloy | Steel | Different  |
|  Front wheel diameter | 193mm | 190mm | Similar  |
|  Front Wheels Quantity | 2 | 2 | Same  |
|  Rear wheel diameter | 193mm | 190mm | Similar  |
|  Rear Wheels Quantity | 2 | 2 | Same  |
|  Ground clearance | 50mm | 45mm | Similar  |
|  Max Loading(on level ground) | 120KG | 120KG | Same  |
|  Turn Radius | 1125mm | 1650mm | Similar  |
|  Motor output | 24 V 250W | 24 V 180W | Similar  |
|  Drive System | Rear Wheel Drive | Rear Wheel Drive | Same  |
|  Brakes | Electromagnetic brake | Electromagnetic brake | Same  |
|  Battery | Li-ion battery 24V5.8Ah*2 | Lead-acid 12V12Ah*2 | Different  |
|  Charger | 29.4V, 2A | 24V, 2A | Different  |
|  Max Speed | 6.84km/h | 6km/h | Similar  |
|  Max Slope | 10° | 9° | Similar  |
|  Travel Distance | 16.3km | 15km | Similar  |
|  Time to brake | < 0.65 s | 0.7-1s | Similar  |
|  Brake Distance-Normal operation (Horizontal-Forward-Max speed) | ≤1.2m | ≤1.5m | Similar  |
|  Total mass | 29KG/31KG | 42KG | Different  |
|  Operating surface & environment | Indoor use and restricted outdoor use on pavements or paved footpaths only. | Indoor use and restricted outdoor use on pavements or paved footpaths only. | Same  |
|  Remote control | No | No | Same  |

# Difference analysis

The design and technological characteristics of the proposed device scooter is similar to the predicate device. There are minor differences between the devices in frame material, size, weight, ground clearance, turn radius, motor output, battery, max speed, max slope, travel distance, brake distance and time to brake. All of the parameters with differences have been tested according to ISO7176 series standards and the test records support its safety and effectiveness. There is no deleterious effect on safety and effectiveness due to the minor differences do not influence the intended use of the device. Therefore, the proposed Scooter is substantially equivalent (SE) to The Scooter (K231428).

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Table 2 safety comparison

|  Item | Subject Device | Predicate Device (K231428) | Results  |
| --- | --- | --- | --- |
|  Biocompatibility | All user directly contacting materials are compliance with ISO10993-1 | All user directly contacting materials are compliance with ISO10993-1 | Same  |
|  EMC | ISO7176-21& IEC 60601-1-2:2014+A1:2020 &IEC TR 60601-4-2:2016 | ISO7176-21& IEC 60601-1-2:2014+A1:2020 | Same  |
|  Performance | ISO7176 series | ISO7176 series | Same  |
|  Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | Same  |
|  Item | Subject Device | Predicate Device (K231428) | Results  |
| --- | --- | --- | --- |
|  ISO7176-1 | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | Same  |
|  ISO7176-2 | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. | Same  |
|  ISO7176-3 | The effectiveness of brakes has been determined after the 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 maximum speed, acceleration and deceleration has been determined after the testing according to the ISO 7176-6. | The maximum speed, acceleration and deceleration has been determined after the testing according to the ISO 7176-6. | Same  |

{9}

|  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  |
|  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  |
|  ISO7176-16 | The performance of resistance to ignition meet the requirements of ISO 7176-16. | The performance of resistance to ignition meet the requirements of ISO 7176-16. | Same  |
|  ISO7176-21 | The EMC performance results meet the requirements of ISO | The EMC performance results meet the requirements of ISO | Same  |

{10}

|   | 7176-21, IEC
60601-1-2:2014+A1:2020
and IEC TR 60601-4-2:2016. | 7176-21, IEC
60601-1-2:2014+A1:2020. |   |
| --- | --- | --- | --- |
|  ISO7176-25 | The performance of batteries and charger of device meet the requirements in Clause 5 and 6 of ISO 7176-25. | The performance of batteries and charger of device meet the requirements in Clause 5 and 6 of ISO 7176-25. | Same  |

## 9. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the proposed Power Mobility scooter, model:MJMA01/MJMA02, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K231428.

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K253936](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K253936)

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