Electric Wheelchair (MP148)

K253870 · Suzhou Master Machinery Manufacturing Co.,Ltd · ITI · Mar 4, 2026 · Physical Medicine

Device Facts

• Record ID: K253870
• Device Name: Electric Wheelchair (MP148)
• Applicant: Suzhou Master Machinery Manufacturing Co.,Ltd
• Product Code: ITI · Physical Medicine
• Decision Date: Mar 4, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

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

Electric wheelchair (MP148) provides mobility for disabled or elderly users. Device consists of a frame, seat, back cushion, armrests, two rear drive wheels, two front casters, and two anti-tip devices. Powered by two 25.2 VDC Lithium-ion batteries; features brushless DC motors and an electronic controller. User operates device via joystick to control speed and direction. Includes automatic electromagnetic brake system. Foldable for storage and transport. Used in indoor and outdoor environments. Provides mobility benefit by allowing independent navigation for individuals with limited physical capacity.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including static/dynamic stability, brake effectiveness, energy consumption, obstacle climbing, and electromagnetic compatibility (EMC) per ISO 7176 series and IEC standards.

Technological Characteristics

Battery-powered (25.2 VDC Li-ion) four-wheeled vehicle with two brushless DC motors. Frame: magnesium alloy; Armrests: polyurethane. Features joystick-based electronic controller and automatic electromagnetic braking. Foldable design. Sterilization: N/A. Connectivity: None. Standards: ISO 7176 series (stability, performance, EMC), ISO 16840-10 (ignition resistance), IEC 62133-2 (battery safety).

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 (K243440)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 4, 2026

Suzhou Master Machinery Manufacturing Co., Ltd
% Xiang Ariel
Senior Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai, 200122
China

Re: K253870
Trade/Device Name: Electric Wheelchair (MP148)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: December 4, 2025
Received: December 4, 2025

Dear Xiang Ariel:

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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K253870 - Xiang Ariel
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 ([e-mail]) or phone [phone] or 301-796-7100).

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K253870 - Xiang Ariel
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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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.

Submission Number (if known)
K253870

Device Name
Electric Wheelchair (MP148)

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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> "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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# 510(k) Summary

Document Prepared Date: 2025/12/03

## Applicant Information:

Suzhou Master Machinery Manufacturing Co., Ltd

Address: No. 379, Jujin Road, Zhangpu Town, Kunshan, Jiangsu, China

Contact person: Hongying Wu

Tel: [phone]

Mail: [e-mail]

Submission Correspondent:

Primary Contact: Ariel Xiang

Shanghai SUNGO Management Consulting Co., Ltd.

14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China

Tel: [phone]

Email: [e-mail]

## Subject Device:

Trade name: Electric Wheelchair

Classification name: Powered wheelchair

Model: MP148

Regulatory Information

Classification: Class II

Product code: ITI

Regulation Number: 890.3860

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Review Panel: Physical Medicine

## Substantial Equivalence Information:

Yongkang Hengyi Vehicle Co., Ltd

Device: Electric Wheelchair

Model(s): HC820N

K243440

## Device Description

The product is intended only carry one person and used as a means of transportation for the disabled, the sick and the infirm.

The electric wheelchair is classified as class A and the maximum occupant mass is 120kg.

The electric wheelchair is a battery powered four wheeled vehicle.

It consists one Lithium battery with an off-board battery charger, frame, controller system, motors, seat, back cushion, armrest, two rear wheels, two casters (front wheels), foot plate, anti-tip devices.

The electric wheelchair can easily fold and unfold for transportation or storage.

## Indication for Use

The electric wheelchair 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.

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# 1. Product Parameter

Table 1 General Comparison

| Elements of Comparison | Subject device (K253870) | Predicate Device (K243440) | Remark |
| --- | --- | --- | --- |
| Manufacturer | Suzhou Master Machinery Manufacturing Co.,Ltd. | Yongkang Hengyi Vehicle Co.,Ltd | -- |
| Common or Usual name | Electric Wheelchair | Electric Wheelchair | -- |
| Model(s) | MP148 | HC820N | -- |
| Classification | Class II | Class II | -- |
| Classification regulation | 21 CFR890.3860 | 21 CFR890.3860 | -- |
| Product code | ITI | ITI | -- |
| 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. | S.E. |
| Intended user | disabled or elderly person limited to a seated position. | disabled or elderly person limited to a seated position. | S.E. |
| Use condition | indoor and outdoor use | indoor and outdoor use | S.E |
| Number of wheels | 6,including two front wheels , two rear wheels,two anti-tips | 6,including two front wheels , two rear Wheels,two anti-tips | S.E |
| 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 | S.E |

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| Movement control method | By Joystick control | By Joystick control | S.E |
| --- | --- | --- | --- |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | S.E |
| Brake system | Automatic electromagnetic brake system | Automatic electromagnetic brake system | S.E |
| Braking distance | ≤1.2m | ≤1.2m | S.E |
| Maximum safe operational incline degree | 10° | 10° | S.E |
| Main frame material | magnesium alloy | Carbon fibers | Different material used for frame, that such difference will not impact the safety and effectiveness of the subject device as the performance tests conducted according to ISO 7176 series. |
| Armrest | Polyurethane | Carbon fibers | Different material used for parts in contact with user, which such differences will not impact the safety and effectiveness of the subject device as biocompatibility tests are carried out according to ISO 10993 series. |
| Overall length | 950mm | 960mm | Minor difference on wheelchair dimension will not cause different performance. All safety and performance have been validated with the maximum rated weight dummy. |
| Overall width | 590mm | 640mm | |

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| Folded Dimension (length*width*height) | 670*280*720mm | 760mmX370mmX720mm | |
| --- | --- | --- | --- |
| Front wheel size/type | 165mm×37mm PU Solid tire | 7" x1.9"/ (Φ175mm*48mm) PU Solid tire | Minor difference on dimension of wheels will not cause different performance. |
| Rear wheel size/type | 253mm×43mm PU Solidc tyre | 11" x 1.9"/ (Φ280mm*48mm) PU Solid tire | |
| Max speed forward | 1.8 m/s | 1.7 m/s (6 km/h) | S.E |
| Max loading weight | 120kg | 120kg | S.E |
| Maximum distance of travel on the fully charged battery | 25.7 km | 13.3 km | It is caused by the size of the wheel, will not cause different performance, The further away the better. |
| Battery | Li-ion battery pack; 25.2 VDC10Ah, 2 pcs | li-ion battery pack 24V,10Ah | The battery capacity will impact the travel distance, which will not cause new safety and effectiveness concerns raised. |
| Battery charger | Off-board charger Input: 110-240V, 50/60Hz, 1.5A Output: 24 Vdc, 2A; | Off-board charger Input: 100-240V, 50/60Hz, 1.5A, Output: 24 Vdc, 2A; | S.E |
| Motor | Brushless DC motor; 24VDC;150W; 2pcs | Brushless DC motor, 24V,150W, 2pcs | S.E |
| Electronic controller | 24V,40A | Brushless dual-drive rocker controller; 24v,40A | S.E |
| Turning Radius | 900 mm | 887.5mm | Minor difference on turning radius will not cause new safety and effectiveness concerns. |
| Maximum obstacle | 20mm | 25mm | Minor difference will not cause new safety and effectiveness |

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Table 2 safety comparison

| Item | Subject device | Predicate Device (K243440) | Results |
| --- | --- | --- | --- |
| Biocompatibility | The biocompatibility of the subject device is based on the use of low-risk biocompatible materials in Attachment G of FDA's 2023 Biocompatibility Guidance. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | S.E. |
| EMC | ISO7176-21, IEC 60601-1-2, IEC 60601-4-2 | ISO7176-21 and IEC 60601-1-2 | S.E. |
| Performance | ISO7176 series | ISO7176 series | S.E. |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | S.E. |
| Item | Subject device | Predicate Device (K243440) | 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. | S.E. |
| 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. | S.E. |
| 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. | S.E. |

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| 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. | S.E. |
| --- | --- | --- | --- |
| 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. | S.E. |
| ISO7176-6 | 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. | S.E. |
| 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. | S.E. |
| 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. | S.E. |
| 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 testsspecified 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. | S.E. |
| 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. | S.E. |
| 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. | S.E. |

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| 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. | S.E. |
| --- | --- | --- | --- |
| 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. | S.E. |
| ISO7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO7176-15. | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15. | S.E. |
| ISO16840-10:2021 | The performance of resistance to ignition meet the requirements of ISO 16840-10:2021. | The performance of resistance to ignition meet the requirements of ISO 16840-10:2021. | S.E. |
| ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21and IEC60601-1-2. | The EMC performance results meet the requirements of ISO 7176-21. | S.E. |
| 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 5and 6 of ISO 7176-25. | S.E. |

## 2. Substantial Equivalence Discussion

The proposed 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

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7176-14, ISO 7176-15, ISO 16840-10, ISO 7176-21, ISO 7176-25, and FDA guidance Submission for Power Wheelchair.

The proposed device performs in a similar manner to the predicate device. All these tests have corresponding requirements/control criteria following above mentioned standards. And the test results show that the subject product is 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.

## 3. Product Performance

The following performance data were provided to verify that the proposed device met all design specifications and provided support of the substantial equivalence determination.

- Risk Analysis developed in accordance with ISO 14971: 2019.

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> Software validation
> ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
> ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric 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 dimensions, mass and maneuvering space
> ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric 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 strength
> 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 7176-14:2022 Wheelchairs -- Part 14: Power and control systems for electrically powered wheelchairs and scooters --

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Requirements and test methods

- ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling.
- ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support 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
- ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures
- ISO 7176-25: 2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs.
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2 and IEC TR 60601-4
- ANSI C63.18-2014 American National Standard Recommended Practice for an On-Site, Ad-Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
- IEC 62133-2:2017+A1:2021 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

Biocompatibility of patient-contacting material

The biocompatibility of the subject device is based on the use of low-risk biocompatible materials in Attachment G of FDA's 2023

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Biocompatibility Guidance.

## 4. 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.

## 5. Substantially Equivalency Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices, K243440 Electric Wheelchair from Yongkang Hengyi Vehicle Co., Ltd.