Electric Wheelchair (DY611A-2, DY612A-1)
Device Facts
| Record ID | K261149 |
|---|---|
| Device Name | Electric Wheelchair (DY611A-2, DY612A-1) |
| Applicant | Zhejiang Lumbre Electric Appliance Co., Ltd. |
| Product Code | ITI · Physical Medicine |
| Decision Date | Jul 10, 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, four-wheeled vehicle; aluminum alloy frame; DC brushless motors; solid PUR tires. Operator uses joystick controller to manage speed, direction, and braking; controller includes power indicator, horn, and speed controls. Device folds for storage. Intended for adult use in indoor/outdoor environments. Provides mobility to disabled or elderly individuals. Performance verified via static/dynamic stability, obstacle climbing, and braking tests. Benefits include improved mobility and independence for users with limited physical capacity.
Clinical Evidence
No clinical data. Bench testing only. Compliance with ISO 7176 series (stability, braking, energy consumption, dimensions, speed, strength, climatic, obstacle-climbing, power/control systems, EMC, battery safety) and ISO 10993-1 (biocompatibility) confirms substantial equivalence.
Technological Characteristics
Aluminum alloy frame; solid PUR tires; DC brushless motors; lithium battery power source. Controller-based operation. Foldable design. Complies with ISO 7176 series (stability, strength, power systems, EMC), IEC 62133-2 (lithium battery safety), IEC 60601-1-2 (EMC), and ISO 10993-1 (biocompatibility).
Indications for Use
Indicated for adult 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 (K250158)
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
July 10, 2026
Zhejiang Lumbre Electric Appliance Co., Ltd.
% Andrew Wang
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,
China
Re: K261149
Trade/Device Name: Electric Wheelchair (DY611A-2, DY612A-1)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: April 7, 2026
Received: April 8, 2026
Dear Andrew 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261149 - Andrew Wang
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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).
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-
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K261149 - Andrew Wang
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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).
Sincerely,
# Tushar Bansal
-S
Digitally signed by Tushar Bansal -S
Date: 2026.07.10 10:38:44
-04'00'
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. | K261149 | ? |
| Please provide the device trade name(s). | | ? |
| Electric Wheelchair (DY611A-2, DY612A-1) | | |
| 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 (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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510(k) #: K261149
510(k) Summary
Prepared on: 2026-06-04
# Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Zhejiang Lumbre Electric Appliance Co., Ltd. |
| --- | --- |
| Applicant Address | No.236, Shanhe Road, Huzhen Town, Jinyun County, Lishui City, Zhejiang Province, China Lishui Zhejiang China |
| Applicant Contact Telephone | +86-18267980685 |
| Applicant Contact | Mr. Yubiao Chen |
| Applicant Contact Email | 858615910@qq.com |
| Correspondent Name | Shanghai SUNGO Management Consulting Co., Ltd. |
| Correspondent Address | 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai China |
| Correspondent Contact Telephone | +86-17521605316 |
| Correspondent Contact | Mr. Andrew Wang |
| Correspondent Contact Email | yuanju.wang@sungoglobal.com |
# Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Electric Wheelchair (DY611A-2, DY612A-1) |
| --- | --- |
| 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 |
| --- | --- | --- |
| K250158 | Electric Wheelchair | ITI |
# Device Description Summary
21 CFR 807.92(a)(4)
The Electric Wheelchair is a battery powered four wheeled vehicle.
Both models (DY611A-2 and DY612A-1) consist one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, power ON/OFF, speed indicator light, decrease speed, increase speed, horn, mute button, joystick, charging port), arm supports, two rear wheels, two casters, foot support, anti-tip devices, push handle.
The wheelchair can easily fold and unfold for transportation or storage.
The wheelchair uses lithium battery as its power source. The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is Aluminum Alloy. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are
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driving wheels to control the speed and direction. The wheels are solid PUR tires.
When in use, the operator drives the motor of the rear wheel by operating the controller to achieve the rear wheels movement.
The DC brushless motor and brake system are fixed on the rear wheels.
The max loading of the device is 100 kg. Only for one person sit.
The intended patient population for this device is adults only.
This device is not intended to be used in the aircraft environment.
## 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)
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.
## Technological Comparison
21 CFR 807.92(a)(6)
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 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. Although there are some differences in technical specifications between the proposed device and the predicate device, these differences do not raise any new questions regarding safety and effectiveness. Specifically, the maximum loading weight of the proposed device is 100kg compared to the predicate's 120kg; the structural safety at 100kg has been fully verified through ISO 7176-8 testing. Furthermore, the proposed models utilize 150W and 200W motors, whereas the predicate utilizes 250W motors. This lower power consumption still provides sufficient driving force, as verified by maximum speed and obstacle-climbing testing. Other minor variations in dimensions, wheel sizes, and driving ranges are standard industry variations to accommodate different user sizes and system efficiencies, and static/dynamic stability tests confirm these physical dimensions are completely safe.
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.
## Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
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 PoweredWheelchairs
ISO 7176-3: 2012, Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electricwheelchairs and wheelchairs for determination of theoretical distance range
ISO 7176-5, Second edition 2008-06-01, 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 Powered Wheelchairs
ISO 7176-7, 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 PoweredWheelchairs
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, First edition 1989-08-01, 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 wheelchairs -
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 devicesRequirements and test method.
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ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers
ISO 7176-25:2022 Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs Requirements and test methods
IEC 62133-2:2017/AMD1:2021 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
IEC 62304:2006/AMD1:2015 Medical device software - Software life cycle processes
IEC 60601-1-2:2014/AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC TS 60601-4-2:2024 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Not Applicable.
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Electric Wheelchair, model(s): DY611A-2, DY612A-1, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K250158.
