Electric Wheelchair (AL-208S-063)
Device Facts
| Record ID | K253340 |
|---|---|
| Device Name | Electric Wheelchair (AL-208S-063) |
| Applicant | Zhongshan A&J Medical Equipment Co., Ltd. |
| Product Code | ITI · Physical Medicine |
| Decision Date | Apr 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3860 |
| Device Class | Class 2 |
Indications 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.
Device Story
Battery-powered, motor-driven wheelchair; user-operated via joystick controller for speed and direction. Components include front/rear frames, backrest, armrests, wheels, battery pack, motor, footplate, and seat cushion. Used in indoor and outdoor environments by disabled or elderly individuals. Provides mobility to users limited to a seated position; weight capacity <100kg. Device transforms user joystick input into motor-driven movement; provides independent mobility for patient.
Clinical Evidence
No clinical data. Safety and performance established via lab bench testing per ISO 7176 series (stability, braking, energy consumption, dimensions, speed/acceleration, strength, climatic, obstacle climbing, power/control systems), ISO 16840-10 (ignition resistance), ISO 7176-21/IEC 60601-1-2 (EMC), IEC 62133-2 (battery safety), and ISO 10993-1 (biocompatibility).
Technological Characteristics
Powered wheelchair; battery-powered motor; joystick control. Dimensions/mass per ISO 7176-5. Biocompatibility per ISO 10993-1. EMC per ISO 7176-21 and IEC 60601-1-2. Battery safety per IEC 62133-2. Mechanical strength/stability per ISO 7176 series. No software algorithm details provided.
Indications for Use
Indicated for disabled or elderly persons limited to a seated position requiring indoor and outdoor mobility assistance. Suitable for users weighing less than 100kg.
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
- Power Wheelchair, W5521 (K231508)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
Zhongshan A&J Medical Equipment Co., Ltd
Yong Li
Official Correspondent
3 Shenghui South Road, Nantou Town
Zhongshan
China
Re: K253340
Trade/Device Name: Electric Wheelchair (AL-208S-063)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: September 23, 2025
Received: September 30, 2025
Dear Yong 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" (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).
April 3, 2026
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253340 - Yong Li
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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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K253340 - Yong Li
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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
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. | K253340 | ? |
| Please provide the device trade name(s). | | ? |
| Electric Wheelchair (AL-208S-063) | | |
| Please provide your Indications for Use below. | | ? |
| 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. | | |
| 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) #: K253340 | 510(k) Summary | Prepared on: 2026-03-02 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD | |
| Applicant Address | 3 Shenghui South Road, Nantou Town Zhongshan China | |
| Applicant Contact Telephone | 86-17382335060 | |
| Applicant Contact | Mr. Yong Li | |
| Applicant Contact Email | mdc-fs@foxmail.com | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Electric Wheelchair (AL-208S-063) | |
| Common Name | Powered wheelchair | |
| Classification Name | Wheelchair, Powered | |
| Regulation Number | 890.3860 | |
| Product Code(s) | ITI | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K231508 | Power Wheelchair, W5521 | ITI |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The proposed device, electric wheelchair, mainly powered by battery, motivated by motor, driven by user controlling joystick and adjusting speed. The electric wheelchair is composed of front frame, rear frame, backrest frame, armrest, front wheel, rear controller, front controller, battery pack, motor rear wheel, footplate, seat cushion, handgrip. The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position. This wheelchair is suitable for the user who with weight less than 100kg. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| 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. | | |
| Indications for Use Comparison | | 21 CFR 807.92(a)(5) |
| The subject device has the same indications for use as the predicate devices as below: 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. | | |
| Technological Comparison | | 21 CFR 807.92(a)(6) |
| The technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. From the results of nonclinical testing described, it can be concluded that the subject Electric Wheelchair is substantially | | |
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equivalent to the legally marketed predicate device cleared under K231508.
# Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The Electric Wheelchair has been evaluated the safety and performance by lab bench testing according to 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
- 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 Set-up procedures
## EMC
- 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 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 62133-2:2017/AMD1:2021
## Biocompatibility
- ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Clinical testing was not performed on the device.
Based on the nonclinical tests, the subject device Electric Wheelchair is as safe and effective as the predicated device
