Mobility Scooter (MS160C)

K251638 · Suzhou Master Machinery Manufacturing Co.,Ltd · INI · Jul 22, 2025 · Physical Medicine

Device Facts

• Record ID: K251638
• Device Name: Mobility Scooter (MS160C)
• Applicant: Suzhou Master Machinery Manufacturing Co.,Ltd
• Product Code: INI · Physical Medicine
• Decision Date: Jul 22, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• 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 mobility scooter; provides indoor/outdoor transport for disabled/elderly users. User operates via control panel (throttle lever, speed dial, horn, battery meter). Motor (24VDC, 150W) drives rear wheels; electromagnetic brakes provide stopping. Components include frame, seat, back support, and anti-tip devices. Battery and seat are removable for transport. Healthcare provider/caregiver does not operate; patient self-operates. Output is physical mobility; device assists users in navigating environments. Benefits include increased independence and mobility for individuals with physical limitations.

Clinical Evidence

No clinical data. Bench testing only. Device verified against ISO 7176 series (stability, braking, energy consumption, dimensions, speed, obstacle climbing, power/control systems, labeling, batteries/chargers) and IEC 60601-1-2/TR 60601-4-2 (EMC). Biocompatibility testing performed per ISO 10993-1, 5, 10, and 23.

Technological Characteristics

Battery-powered 4-wheel scooter. Materials: Aluminum alloy frame; PVC/sponge (seat/backrest/grips); PEVA (foot support); ABS (throttle). Sensing/Actuation: DC brushless motor, electromagnetic brakes. Connectivity: None. Power: 24VDC, 150W motor; 2x 12V Lead-acid batteries. Dimensions: 1150x511x900mm. Foldable design. Standards: ISO 7176 series, ISO 10993 series, IEC 60601-1-2.

Indications for Use

Indicated for disabled or elderly persons with mobility difficulties who are limited to a seated position.

Regulatory Classification

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 (Model: W3468) (K220207)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 22, 2025

Suzhou Master Machinery Manufacturing Co., Ltd.
% Boyle Wang
General Manager
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong
Shanghai, 200120
China

Re: K251638
Trade/Device Name: Mobility Scooter (MS160C)
Regulation Number: 21 CFR 890.3800
Regulation Name: Motorized Three-Wheeled Vehicle
Regulatory Class: Class II
Product Code: INI
Dated: May 29, 2025
Received: May 29, 2025

Dear Boyle Wang:

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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K251638 - Boyle Wang
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(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-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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K251638 - Boyle Wang
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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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Mobility Scooter
Page 12 of 67

| 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. | K251638 | ? |
| Please provide the device trade name(s). | | ? |
| Mobility Scooter (MS160C) | | |
| 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

# 510(k) Summary

# K251638

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

## 1.0 Submitter's information

Name: Suzhou Master Machinery Manufacturing Co., Ltd.

Address: 2/F, Block B, No. 379, Delan Industrial Park, Zhangpu Town, Kunshan City, Jiangsu Province, China.

Tel: [phone]

Fax: 86-512 - 57452992

Contact: Siqi.Shangguan

Date of Preparation: Jul.10, 2025

## Designated Submission Correspondent

Mr. Boyle Wang

Shanghai Truthful Information Technology Co., Ltd.

Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China

Tel: [phone]

Email: [e-mail]

## 2.0 Device information

Trade name: Mobility Scooter

Common name: Scooter

Classification name: Motorized Three-Wheeled Vehicle

Model(s): MS160C

## 3.0 Classification

Production code: INI

Regulation number: 21 CFR 890.3800

Classification: Class II

Panel: Physical Medicine

## 4.0 Predicate device information

Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

Trade/Device: Mobility Scooter (Model: W3468)

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510(k) Summary

510(k) number: K220207

## 5.0 Indication for Use Statement

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.

## 6.0 Device description

The product is a Mobility Scooter which provides transport for the disabled and the elderly and to be used both indoors and outdoors.

This scooter is a battery powered four wheeled vehicle. It consists two Lead-acid batteries (in the battery box) with an off-board battery charger, frame, a seat, a back support, control panel (including the key switch, throttle control lever, horn button, speed adjustment dial, and the battery condition meter), two foldable handles, two rear drive wheels with motor/ e-magnetic brake components, two front wheels, anti-tip devices, an external battery charger, a control panel and a motor controller. For convenience of transportation and reduction of possible damage, the battery and the seat unit can be dismantled and separately packaged.

The front wheels of the scooter are 8 inches and the rear wheels are 9 inches.

The motor of the scooter is 24VDC,150W,4200RPM; the Lead-acid Battery is 12 V, 22 Ah, 18.7 Ah; the charger is 24V/2A.

Max. loading cannot be over than 180kg.

The maximum distance travelled with a fully charged battery is 17.5km and the maximum forward speed is 1.6m/s(5.8km/h).

Braking time is less than 2 seconds, braking distance is ≤1.0 meters.

## 7.0 Summary of Non-Clinical Testing

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 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

ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs

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510(k) Summary

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 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures
ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC TR 60601-4-2 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

## Biocompatibility of patient-contacting parts

Patient-contacting material are carried out biocompatibility assessment in accordance with ISO 10993-1: 2018, including:

Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

Skin Sensitization per ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization.

Irritation per ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests For Irritation.

## 8.0 Summary of Clinical Testing

No clinical study implemented for the scooter.

## 9.0 Technological Characteristic Comparison Table

Table 1 - General Comparison

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510(k) Summary

| Item | Subject Device K251638 | Predicate Device K220207 | Remark |
| --- | --- | --- | --- |
| Product Code | INI | INI | Same |
| Regulation No. | 21 CFR 890.3800 | 21 CFR 890.3800 | Same |
| Class | II | II | Same |
| Product name | Scooter (Model: MS160B) | Scooter (Model: W3468) | - |
| Intended Use/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. | 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 environment | Indoor and outdoor use | Indoor and outdoor use | Same |
| Patient Population | This product is suitable for disabled people with mobility difficulties and elderly people. | This product is suitable for disabled people with mobility difficulties and elderly people. | Same |
| Product structure | It consists two Lead-acid batteries (in the battery box) with an off-board battery charger, frame, a seat, a back support, control panel (including the key switch, throttle control lever, horn button, speed adjustment dial, and the battery condition meter), two foldable handles, two rear drive wheels with motor/ e-magnetic brake components. | It has a base with Steal frame, two front wheels, two rear wheels, a seat, a tiller console, electric motor, electromagnetic brake, front light, USB charging port (Transfer power only), 2 rechargeable Lead-acid Batteries with an off-board charger | Similar |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Number of wheels | 4 | 4 | Same |
| Main frame material | Aluminium alloy | Steel | Different |
| Motor | Brushless motor, DC24V * 180W * 1 pcs | Brushless motor, 250W | Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Battery | Lead Acid DC 12 V,22 Ah, 18.7 Ah 2 pc | Lead Acid12V x 2 (22Ah) 2pc | |
| Battery charger | Off-board charger 24V/2A | Off-board charger 24V/2A | |

Table 2 - Performance Comparison

| Item | Subject Device | Predicate Device K220207 | Remark |
| --- | --- | --- | --- |

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510(k) Summary

| Dimensions (mm) | 1150x511x900 | 1075 x 510 x 930 | Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| --- | --- | --- | --- |
| Folded dimensions (mm) | 1100x500x390 | Not Publicly Available | Minor differences in the folded dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Weight, w/ Battery | 110.2lbs. /50kg | 127.9lbs. /58kg | Both the proposed and predicate devices meet the performance testing standards ISO 7176 series. |
| Frame design | Foldable/
The electric scooter is an auxiliary walking tool powered by electricity. It can be folded after removing the battery, convenient for transport and storage. | Foldable/
The electric scooter is an auxiliary walking tool powered by electricity. It can be folded after removing the battery, convenient for transport and storage. | Same |
| Seating Design | The seat height is adjustable to suit different users, and the armrests can be adjusted in width or flipped up to facilitate getting on and off. The seat can be easily removed for folding and transportation. | The seat height is adjustable to suit different users, and the armrests can be adjusted in width or flipped up to facilitate getting on and off. The seat can be easily removed for folding and transportation. | Same |
| Folding mechanism | A foldable seat frames
(The backrest could be folded to seat) | A foldable seat frames
(The backrest could be folded to seat) | Same |
| Front wheel(inch) | 8
(PU tire) | 9 | Different sizes of wheel will not affect safety and performance of the subject device as all related stability tests are performed according to standard ISO 7176 series. |
| Rear tire (inch) | 9
(PU tire) | 9 | Same |
| Anti-tip Wheels (inch) | 2.5 | 2.5 | Same |

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510(k) Summary

| Cruising Range(km) | 17.5 | 20km | The difference will not raise any new safety and effectiveness concerns. |
| --- | --- | --- | --- |
| Obstacle climbing(mm) | 10 | Not Publicly Available | The difference will not raise any new safety and effectiveness concerns. |
| Ground clearance | 63mm | 85mm | The device has been tested according to ISO7176 series standards and the test records support its safety and effectiveness. |
| Max. loading (kg) | 396.83 lbs(180kg) | 352.7lbs(160kg) | The difference will not raise any new safety and effectiveness concerns. |
| Slope Grade Ability | 14 degree | 9 degree | Larger safe operational incline of subject brings more convenient for the use environment |
| Min. Turning radium | 1500mm | 1800mm | The little difference in the turning radius will not raise any new safety and effectiveness concerns. |
| Minimum braking distance | 1.0m for the speed of 5.78 km/h
1s | ≤1.5m for the speed of 6.4km/h
1s | The subject device complies with the requirements of ISO 7176-3 |
| Max Speed Forwards | 1.6 m/s (5.78 km/h) | 1.8 m/s (6.4 km/h) | The devices are evaluated according to standard ISO 7176-6:2018, so the different will not impact the safety and effectiveness |
| Max. Speed Backward | 0.6 m/s (2.16 km/h) | Not Publicly Available | |
| Controller | Dynamic
DR50-B01 | Dynamic
PG45A | Although different controller is used, both the control system, including the electromagnetic brakes and the user interface are similar.
Both of the control systems are evaluated according to standard ISO7176-14:2008 and software validation requirement and there are no new safety and effectiveness concerns due to the difference. |

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510(k) Summary

Table 3 - Safety Comparison

| Item | Proposed Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| Materials contacting user | Hand grips: PVC; Backrest (Back support): PVC, sponge; Armrest (Arm support): PVC, sponge; Seat: PVC, sponge; Foot support pad: PEVA; Throttle controller lever: ABS. | Hand grips: PVC; Backrest (Back support): PVC, sponge; Armrest (Arm support): PVC, sponge; Seat: PVC, sponge; Foot support pad: PEVA; Throttle controller lever: ABS. | Same |
| Biocompatibility of materials contacting user | Comply with ISO 10993-1, FDA Guidance | Comply with ISO 10993-1, FDA Guidance, Tests included: Cytotoxicity (ISO 10993-5:2009), Skin Sensitization test (ISO 10993-10:2021) Intracuaneous Reactivity Test (ISO 10993-23:2021) | Same |

Summary of substantial equivalence discussion:

Despite of the above slight differences, the two devices all completed the performance tests in accordance with ISO 7176 series standards. There are no safety and effectiveness aspects concerned. In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The slight differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

10.0 Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicated device in K220207 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.

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