(29 days)
Not Found
No.
The device description does not mention any AI, DNN, or ML models. The control system is based on a joystick and remote control via Bluetooth, with electromagnetic brakes actuated when the joystick is released. There are no indications of autonomous decision-making or learning functionalities.
No
A power wheelchair is for mobility assistance, not for treating or diagnosing a medical condition or disease.
No
The device is a power wheelchair, described as a transportation vehicle to provide mobility. There is no indication that it is used to diagnose any medical conditions.
No
The device is a physical power wheelchair with numerous hardware components (motors, batteries, frame, wheels, etc.) and a control system that includes both hardware (joystick, control pad) and software elements. It is not limited to software functionality.
No
The device is a power wheelchair, a mobility aid that does not perform diagnostic tests on in vitro biological samples.
N/A
Intended Use / Indications for Use
The power 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.
Product codes
ITI
Device Description
The power wheelchair, model name:D26, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-Ion battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.
The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
The power wheelchair, model name: D26, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design.
The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
disabled or elderly person limited to a seated position / indoor and outdoor use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The performance testing demonstrates that the subject device is substantially equivalent to the predicate devices regarding Static ability, The Dynamic stability, 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3860 Powered wheelchair.
(a)
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.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - Power Wheelchair (D26)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 25, 2025
Anhui JBH Medical Apparatus Co., Ltd.
℅ Kiwi Xu
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Century Ave.
Shanghai,
China
Re: K251606
Trade/Device Name: Power Wheelchair (D26)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: May 27, 2025
Received: May 27, 2025
Dear Kiwi Xu:
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.
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K251606 - Kiwi Xu
Page 2
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 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-
Page 3
K251606 - Kiwi Xu
Page 3
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
for Heather Dean, PhD
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
Page 4
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. K251606
Please provide the device trade name(s). Power Wheelchair (D26)
Please provide your Indications for Use below.
The power 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)
Power Wheelchair
Page 11 of 28
Page 5
510k summary
1 SUBMITTER
Name: Anhui JBH Medical Apparatus Co., Ltd.
Address: No. 116 Qicang Road, Industrial District, Ming Guang City, Chuzhou, Anhui, China
Name of contact person: Wei Yuanwei
Telephone: +86-0550-8108866
Fax: +86-0550-8106688
Email: outreach@jbhmedical.com
Date prepared: 2025.5.23
2 Device
K251606
Device trade name: Power wheelchair
Model: D26
Classification name: Powered wheelchair
Regulation class: 2
Regulation number: 21CFR 890.3860
Panel: Physical Medicine
Product code: ITI
3 Predicate device
K242448
Power Wheelchair, D26
Anhui JBH Medical Apparatus Co., Ltd
4 Device description
The power wheelchair, model name:D26, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-Ion
Page 6
battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.
The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
The power wheelchair, model name: D26, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design.
The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
5 Indication for use
The power 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.
6 Comparison of technological characteristics with the predicate device
Table 1 General Comparison
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Manufacturer | Anhui JBH Medical Apparatus Co., Ltd. | Anhui JBH Medical Apparatus Co., Ltd. | / |
| Proprietary name, model | Power Wheelchair, D26 | power wheelchair, D26 | / |
| 510(k) number | - | K242448 | / |
| Device classification name | Class II | Class II | Same |
| Classification regulations | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Product code | ITI | ITI | Same |
Page 7
| Indication for use | The Power 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. | The wheelchair (Model: DC01) 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 or elderly person limited to a seated position | disabled or elderly person limited to a seated position | Same |
| Use condition | indoor and outdoor use | indoor and outdoor use | Same |
| Type of use | OTC | OTC | Same |
Table 2 Basic Parameters Comparison
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Device length | 1150 mm | 1150 mm | Same |
| Device Width | 600 mm | 600 mm | Same |
| Stowage Length | 600 mm | 600 mm | Same |
| Stowage width | 340 mm | 340 mm | Same |
| Stowage height | 810 mm | 810 mm | Same |
| Ground clearance | 110 mm | 110 mm | Same |
| Number of wheels | 4 | 4 | Same |
| Front wheel size/type | 7" /PU Solid tire | 7" /PU Solid tire | Same |
| Rear wheel size/type | 12" /PU Solid tire | 12" /PU Solid tire | Same |
| 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 | Same | ||
| Frame design | The frame of the wheelchair is type capable of front and rear close. The main part of the frame can be folded for saving space and convenient storage and transportation. | The frame of the wheelchair is type capable of front and rear close. The main part of the frame can be folded for saving space and convenient storage and transportation. | Same |
| Folding mechanism | Manually fold/ expand | Manually fold/ expand | Same |
Page 8
| Movement control method | By Joystick control and Bluetooth remote controller | By Joystick control and Bluetooth remote controller | Same |
|---|---|---|---|
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Brake system | Intelligent electromagnetic brake system | Intelligent regenerative Electromagnetic brake | Same |
| Max speed forward | Up to 6 km/h (3.75 mph), continuously adjustable | Up to 6 km/h (3.75 mph), variable | Same |
| Main frame material | Aluminum alloy | Aluminum alloy | Same |
| Armrest cushion | Polyurethane (PU) | Polyurethane (PU) | Same |
| Speed settings | 5 | 5 | Same |
| Battery | li-ion battery; rechargeable, 24 VDC 10Ah/ 6Ah*2 | li-ion battery; rechargeable, 24 VDC 10Ah/ 6Ah*2 | Same |
| Maximum distance of travel on the fully charged battery | 12.8 km | 20 km | Minor difference on travel distance will not cause different performance. This difference will not raise any new safety and effectiveness concerns. |
| Battery charger | Off-board charger | ||
| Input: 100-240Vac, 50/60Hz, 1.5A | |||
| Output: 24 Vdc, 2A | Off-board charger | ||
| Input: 100-240Vac, 50/60Hz, 1.5A | |||
| Output: 24 Vdc, 2A | Same | ||
| Minimum braking distance from maximum speed | Forward: ＜1m | Forward: ＜1m | Same |
| Max loading weight | 180kg | 120kg | Minor difference on loading weight will not cause different performance. more loading weight provide more convenient and stable performance for the transportation. |
| Maximum safe operational incline degree | 8 ° | 8 ° | Same |
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| Motor | Brushless motor; 24VDC; 250W; 2pcs | Brushless motor; 24VDC; 250W; 2pcs | Same |
|---|---|---|---|
| Electronic controller | Dual Drive Controller for Brushless Motor | Dual Drive Controller for Brushless Motor | Same |
| Remote controller | Via Bluetooth | Via Bluetooth | Same |
| Wireless RF frequency range | 2.402 GHz to 2.480 GHz | 2.402 GHz to 2.480 GHz | Same |
| Wireless operation range | 10m | 10m | Same |
| Turning Radius | 750mm | 750mm | Same |
| Maximum obstacle climbing | 25 mm | 25 mm | Same |
| seat cushion/ back cushion | mesh fabric + sponge | mesh fabric + sponge | Same |
Table 3 Safety comparison
| Attribute | Subject device | Predicate device | Discussion/Conclusion |
|---|---|---|---|
| Biocompatibility | All user directly contacting materials are compliance with ISO 10993-1 | All user directly contacting materials are compliance with ISO 10993-1 | Same |
| EMC | ISO 7176-21 & IEC60601-1-2 | ISO 7176-21 & IEC60601-1-2 | Same |
| Performance | ISO 7176 series | ISO 7176 series | Same |
| Labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | Same |
7 Summary of substantial equivalence discussion
The proposed device and predicate device are complying to the same ISO standards, ISO 7176-1:2014, ISO 7176-2:2017, 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, ISO 7176-13:1989, ISO 7176-14:2022, ISO 7176-15:1996, ISO 16840-10:2021, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2020 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.
Page 10
The performance testing demonstrates that the subject device is substantially equivalent to the predicate devices regarding Static ability, The Dynamic stability, 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 biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO10993-10:2010/ ISO 10993-23:2021. Although the standard version updated, test methods for the subject device and the predicate device are same.
8 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.
9 Substantially Equivalence Conclusion
Based on the comparison and analysis above, the subject device is determined to be substantially equivalent to the predicate device, K242448.