← Product Code [ITI](/productcode/ITI) · K261354

# Electric wheelchair (D03) (K261354)

_Foshan Sowell Medical Technology Co., Ltd. · ITI · Aug 21, 2026 · Physical Medicine · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K261354

## Device Facts

- **Applicant:** Foshan Sowell Medical Technology Co., Ltd.
- **Product Code:** [ITI](/productcode/ITI.md)
- **Decision Date:** Aug 21, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3860
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine
- **Attributes:** Therapeutic

## 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

Electric wheelchair (D03) provides mobility for disabled or elderly users; operated via joystick control. Device consists of frame, seat/back cushions, armrests, four wheels, two rear-wheel motors, two anti-tilt wheels, and Li-ion battery. Electromagnetic brake engages automatically when not in use. Designed for flat, hard surfaces. User controls speed and direction via joystick; output is physical movement of the wheelchair. Benefits include increased independence for individuals with mobility difficulties. Device is foldable for storage.

## Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including software validation and compliance with ISO 7176 series (stability, braking, energy consumption, dimensions, speed, strength, climatic, obstacle-climbing, power/control systems, EMC) and ISO 16840-10 (flame retardancy).

## Technological Characteristics

Powered wheelchair; frame construction; DC brushless motors (24VDC, 250W); Li-ion battery (25.9VDC, 10Ah); PU solid tires; nylon seat/back cushions; electromagnetic braking system. Connectivity: None. Sterilization: N/A. Software: Embedded control system validated per ISO 7176-14.

## Regulatory 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

- Electrically powered wheelchair ([K252494](/device/K252494.md))

## Submission Summary (Full Text)

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**FDA U.S. FOOD & DRUG**
ADMINISTRATION

August 21, 2026

Foshan Sowell Medical Technology Co., Ltd.
% Eva Li
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.,
Shanghai, 200122
China

Re: K261354

Trade/Device Name: Electric wheelchair (D03)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: July 20, 2026
Received: July 20, 2026

Dear Eva Li:

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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K261354 - Eva Li

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), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (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 ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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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K261354 - Eva Li

Page 3

Sincerely,

![img-0.jpeg](img-0.jpeg)

Digitally signed by

MARY S. KESZLER -S

Date: 2026.08.21

14:34:44 -04'00'

for 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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|  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. | K261354 | ?  |
|  Please provide the device trade name(s). |   | ?  |
|  Electric wheelchair (D03)  |   |   |
|  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 (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ?  |
|  Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ?  |

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Foshan Sowell Medical Technology Co., Ltd.

2nd to 3rd floors of Building 1, No. 12, Zone D1/No. 15, Zone C1, Donglian Masha Industrial Avenue, Danzao Town, Nanhai District, Foshan City, Guangdong Province, China

# 510(k) Summary

# K261354

# I. SUBMITTER

Name: Foshan Sowell Medical Technology Co.,Ltd.

Address: 2nd to 3rd floors of Building 1, No. 12, Zone D1/No. 15, Zone C1, Donglian Masha Industrial Avenue, Danzao Town, Nanhai District, Foshan City, Guangdong Province, China

Telephone: 00864008520172

Email: sowell@sowellmed.com

Date prepared: April 10,2026

# II. Device

Device trade name: Electric wheelchair

Model: D03

Common name: Electric wheelchair

Classification name: Powered wheelchair

Regulation class: 2

Regulation number: 21CFR 890.3860

Panel: Physical Medicine

Product code: ITI

# III. Predicate device

K252494

Electrically powered wheelchair

Nanjing Kangni Smart Technology Co.,Ltd.

# IV. Device Description

The Electric wheelchair mainly consists: a frame (a front wheel bracket, a motor frame, a seat frame, a backrest frame), armrests, a controller, a driver, a seat cushion, a back cushion, footrests, 4 wheels, 2 rear wheel motors, 2 anti-tilt wheels, a safety belt and 1 Li-ion battery pack.

The device can be unfolded and folded.

The device is installed with an electromagnetic brake that will engage automatically when the device is not in use and the brake cannot be used manually. The device only can be operated on the flat and hard surface.

# V. 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.

# VI. Comparison of technological characteristics with the predicate device

1 / 5

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Foshan Sowell Medical Technology Co., Ltd.

2nd to 3rd floors of Building 1, No. 12, Zone D1/No. 15, Zone C1, Donglian Masha Industrial Avenue,

Danzao Town, Nanhai District, Foshan City, Guangdong Province, China

|  Item | predicate device | Subject device | Comparison  |
| --- | --- | --- | --- |
|  Manufacturer | Nanjing Kangni Smart Technology Co.,Ltd. | Foshan Sowell Medical Technology Co.,Ltd | NA  |
|  Proprietary name, model | Electrically powered wheelchair , KZ301B | Electric wheelchair, D03 | NA  |
|  510(k) number | K252494 | K261354 | NA  |
|  Device classification name | Class II | Class II | same  |
|  Classification regulations | 21 CFR 890.3860 | 21 CFR 890.3860 | same  |
|  Product code | ITI | ITI | same  |
|  Indication for use | The Electrically powered 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. | 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  |
|  Intended user | disabled people with mobility difficulties and elderly people | disabled people with mobility difficulties and elderly people | same  |
|  Use condition | indoor and outdoor use | indoor and outdoor use | same  |
|  Number of wheels | 6, including two front wheels ,two rear wheels, two anti-tip wheels | 6, including two front wheels and two rear wheels, two anti-tip wheels | same  |
|  Function of wheels | Front wheels: driven wheels Rear wheels: driving wheels Anti-tip wheels: preventing the wheelchair from tipping turning over when driving on the slope. Non-adjustable. | Front wheels: driven wheels suitable for rotation, acceleration, retrograde Rear wheels: driving wheels to control the speed and direction Anti-tip wheels: preventing the wheelchair from tipping turning over when driving on the slope. Non-adjustable | same  |
|  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 electromagnetic brake system | Automatic electromagnetic brake system | Same  |
|  Battery charger | Off-board charger Input : 100-240V, 50/60Hz, | Off-board charger Input: 100-240V, 50/60Hz,2A, | Similar  |

2 / 5

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# Foshan Sowell Medical Technology Co., Ltd.

2nd to 3rd floors of Building 1, No. 12, Zone D1/No. 15, Zone C1, Donglian Masha Industrial Avenue, Danzao Town, Nanhai District, Foshan City, Guangdong Province, China

|   | 1.5A, DC output: 24V 2A | Output: 24.9 Vdc, 2A; |   |
| --- | --- | --- | --- |
|  back cushion | Nylon | Nylon | same  |
|  seat cushion | Nylon | Nylon | same  |
|  Armrest | PUR | Nylon | same  |
|  Max loading weight | 120Kg | 125kg | different  |
|  Max obstacle climbing | 40mm | 15 mm | different  |
|  Total mass | 35kg | 22kg | different  |
|  Overall Dimension (length*width*height)(mm) | 1120mmX590mmX885mm | 960mmX560mmX820mm | Different  |
|  Stowage Dimension (length*width*height)(mm) | 520mmX590mmX885mm | 800mmX560mmX820mm | Different  |
|  Front wheel size/type | 7.5" PU Solid Tires | 7 inch PU Solid tire | Different  |
|  Rear wheel size/type | 12.5" PU Solid Tires | 12 inch/ PU Solid tire | Different  |
|  Max speed forward | Up to 5.9km/h(1.64m/s), adjustable | Up to 5.76 km/h(1.6m/s), adjustable | Different  |
|  Max Speed backward | Less than 1.08 km/h (0.3m/s) | Less than 1.8 km/h (0.5m/s) | Different  |
|  Maximum safe operational incline degree | 9° | 10° | Different  |
|  Braking distance | ≤1 m | ≤1 m | Same  |
|  Battery | li-ion battery pack; rechargeable, 24 VDC 6Ah | li-ion battery pack; rechargeable, 25.9VDC 10Ah | similar  |
|  Maximum distance of travel on the fully charged battery | 19.8km | 12.2km | different  |
|  Motor | Brushless DC motor; 24VDC 250W; 2pc | DC brushless motor; 24VDC; 250W; 2pcs | same  |
|  Turning Radius | 950mm | 825 mm | different  |

Discussion: The difference between the subject device and predicate device will not raise any effectiveness or safety issues since the subject device meet the related requirement of series standard of ISO 7176.

3 / 5

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Foshan Sowell Medical Technology Co., Ltd.

2nd to 3rd floors of Building 1, No. 12, Zone D1/No. 15, Zone C1, Donglian Masha Industrial Avenue,

Danzao Town, Nanhai District, Foshan City, Guangdong Province, China

# VII. Summary of substantial equivalence discussion

The subject device complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2001, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2008, ISO7176-13:1989, ISO 7176-14:2022, ISO 7176-15:1996, ISO 16840-10: 2021, ISO7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2020

The intended uses for both devices are the same.

The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14:2022.

Software validation is carried out on both control systems.

Brake system are different, it meets the requirements of the ISO 7176-3:2012.

Turning radius and Maximum safe operational incline are slightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-2:2001, ISO 7176-10:2008.

The flame retardant test of the seat cushion/backrest of the subject device is conducted according to ISO 16840-10. Therefore, both devices are assured to be under the same safety level.

The all rest different between the subject device and predicate device can proved the safety or effectiveness by the ISO 7176 series support reports.

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 differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

# VIII. Summary of non-clinical testing

➤ Performance testing-bench

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

- 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,

4 / 5

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Foshan Sowell Medical Technology Co., Ltd.

2nd to 3rd floors of Building 1, No. 12, Zone D1/No. 15, Zone C1, Donglian Masha Industrial Avenue,

Danzao Town, Nanhai District, Foshan City, Guangdong Province, China

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 -- 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 - Batteries and chargers for powered wheelchairs Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
- 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

# Biocompatibility of patient-contacting material

The biocompatibility of the subject device is based on the use of low-biocompatibility risk materials and supporting information in accordance with Attachment G of FDA's 2023 Biocompatibility Guidance.

# IX. 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 electric wheelchair to its predicate device.

# X. Conclusions

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K252494

5 / 5

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**Source:** [https://fda-staging.innolitics.com/device/K261354](https://fda-staging.innolitics.com/device/K261354)

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