Electric wheelchair (JJW-7002, JJW-7003)

K253849 · ZheJiang J&J Mobility Co., Ltd. · ITI · Mar 20, 2026 · Physical Medicine

Device Facts

• Record ID: K253849
• Device Name: Electric wheelchair (JJW-7002, JJW-7003)
• Applicant: ZheJiang J&J Mobility Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Mar 20, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

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 electric wheelchair; user-operated via joystick controller; DC motor drive. Inputs: user joystick movement (direction/speed), speed control button settings. Processing: controller interprets joystick displacement to modulate motor speed/direction; solenoid brake engages upon joystick release or power-off. Outputs: mechanical propulsion; speed/direction changes. Used in indoor/outdoor environments by disabled or elderly patients. Provides mobility; enhances independence. Features quick assembly/disassembly for transport.

Clinical Evidence

No clinical data or animal studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including static/dynamic stability, braking performance, energy consumption, obstacle climbing, and EMC/electrical safety testing per ISO 7176 series and IEC 60601-1-2.

Technological Characteristics

Carbon fiber frame; DC brushless motor; Li-ion battery; joystick-based electronic control system. Automatic electromagnetic braking. Dimensions vary by model. Complies with ISO 7176 series (stability, braking, dimensions, fatigue, climatic, obstacle climbing, batteries/chargers) and IEC 60601-1-2 (EMC). Biocompatible materials per ISO 10993.

Indications for Use

Indicated for 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 (K252671)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 20, 2026

ZheJiang J&J Mobility Co., Ltd.
% Kiwi Xu
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,
China

Re: K253849
Trade/Device Name: Electric wheelchair (JJW-7002, JJW-7003)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: December 2, 2025
Received: December 2, 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253849 - 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 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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K253849 - Kiwi Xu
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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).

Sincerely,

DIGITALLY SIGNED BY
MARY S. KESZLER-S
Date: 2026.03.20
08:56:06 -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. | K253849 | ? |
| Please provide the device trade name(s). | | ? |
| Electric wheelchair (JJW-7002,JJW-7003) | | |
| 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) | |

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ZheJiang J&J Mobility Co., Ltd.
#18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

# 510k Summary

# K253849

## Submitter:

Name: ZheJiang J&J Mobility Co., Ltd.

Address: #18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

Contact: Linda Cheng

Email: [e-mail]

Prepared on: November 30, 2025

## Device:

Device Trade Name: Power Wheelchair

Model: JJW-7002, JJW-7003

Classification name: Powered wheelchair

Regulation class: 2

Regulation number: 21CFR 890.3860

Panel: Physical Medicine

Product code: ITI

## Predicate device:

510(k) number: K252671

Device Trade Name: Electric Wheelchair

Model: NSDS-01

Hebei Dansong Medical Technology Co., Ltd.

## Device description:

The subject device, Electric Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use.

The Electric Wheelchair is a battery powered four wheeled vehicle. It consists of Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.

The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the Joystick can

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ZheJiang J&J Mobility Co., Ltd. #18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric/ manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Electric Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.

When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate and friction plate to lock the motor, so as to brake.

The braking time is about 1s, and the braking distance is $\leq 1.0\mathrm{m}$

## 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.

## 1. Product Parameters

Table 1 General Comparison

| Elements of Comparison | Subject Device | Predicate Device (K252671) | Remark |
| --- | --- | --- | --- |
| Manufacturer | ZheJiang J&J Mobility Co., Ltd. | Hebei Dansong Medical Technology Co., Ltd. | - |
| Common or Usual name | Electric Wheelchair | Electric Wheelchair | Same |
| Model(s) | JJW-7002/JJW-7003 | NSDS-01 | -- |
| 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. | 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 condition | indoor and outdoor use | indoor and outdoor use | Same |
| Number of wheels | 4, including two front wheels and two rear Wheels | 4, including two front wheels and two rear Wheels | Same |

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ZheJiang J&J Mobility Co., Ltd.
#18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

| 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 |
| --- | --- | --- | --- |
| Movement control method | By Joystick control | By Joystick control | Same |

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ZheJiang J&J Mobility Co., Ltd.
#18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

| Elements of Comparison | Subject Device | Predicate Device (K252671) | Remark |
| --- | --- | --- | --- |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Brake system | Automatic electronic brake system | Automatic electromagnetic brake system | Same |
| Braking distance | ≤1.0 m | ≤1.5 m | Analysis: Slightly difference on the parameter will not affect the safety and performance of the subject device as all related stability tests are performed according to standard ISO 7176 series. |
| Maximum safe operational incline degree | Model JJW-7002: 10 ° | 6 ° | |
| | Model JJW-7003: 6 ° | | |
| Battery charger | Off-board charger Input: 100-240V, 50/60Hz, 1.8A, Output: 24V, 3.0A | Off-board charger Input: 220V, 50Hz, 88W, Output: 24 V-29.9V, 3A; | Analysis: Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Main frame material | Carbon fiber | Aluminum alloy | |
| Overall Dimension (length*width*height) | Model JJW-7002: 1020×660×930 mm | 1100×650×960 mm | Analysis: Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| | Model JJW-7003: 420×600×820 mm | | |
| Folded Dimension (length*width*height) | Model JJW-7002: 560×620×870 mm | 810×430×650 mm | |
| | Model JJW-7003: 780×310×770 mm | | |
| Front wheel size/type | Model JJW-7002: 175mm/ PU | 8"/Poly -edge PU foam | Analysis: Different sizes and type of rear wheel will not affect the safety and performance of the subject device as all related stability tests are performed according to standard ISO 7176 series. |
| | Model JJW-7003: 185mm/ PU | | |
| Rear wheel size/type | Model JJW-7002: 210mm×50mm/ PU | 12.5" x 2.25"/Poly -edge PU foam | |
| | Model JJW-7003: 12inch×1.75inch/ PU | | |

{8}

ZheJiang J&J Mobility Co., Ltd.
#18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

| Elements of Comparison | Subject Device | Predicate Device (K252671) | Remark |
| --- | --- | --- | --- |
| Max speed forward | 6 km/h | 6.48 km/h(1.8 m/s) | Analysis: Slightly difference on the parameter will not affect the safety and performance of the subject device as all related stability tests are performed according to standard ISO 7176-6:2018. |
| Max Speed backward | Model JJW-7002: Less than 3 km/h (0.8m/s) | Less than 3 km/h (0.8m/s) | |
| | Model JJW-7003: Less than 3.24 km/h (0.9m/s) | | |
| Max loading weight | 136kg | 150 kg | Analysis: The subject device complies with ISO 7176 series test. The test report can prove that this maximum load capacity is safe. |
| Battery | Model JJW-7002: 24V 7.5Ah Lithium-ion battery ×2 | 25.55V 13Ah Lithium-ion battery | Analysis: The subject device complies with ISO 7176-25: 2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs and EMC testing, these differences do not affect safety and effectiveness. |
| | Model JJW-7003: 24V 10Ah Lithium-ion battery ×1 | | |
| Maximum distance of travel on the fully charged battery | Model JJW-7002: 18.4 km | 11 km | Analysis: The subject device complies with ISO 7176-4: 2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range, these differences do not affect safety and effectiveness. |
| | Model JJW-7003: 13.7km | | |
| Motor | Brushless motor;24V; 250W | Brushed DC motor; 24V; 250W | Analysis: The subject device complies with ISO 7176 series test. The test report can prove that this maximum load capacity is safe. |
| Electronic controller | Brushless dual-drive rocker controller | Brushless dual-drive rocker controller | Same |

{9}

ZheJiang J&J Mobility Co., Ltd.
#18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

| Elements of Comparison | Subject Device | Predicate Device (K252671) | Remark |
| --- | --- | --- | --- |
| Turning Radius | Model JJW-7002: 950mm | 975mm | Analysis: The predicate device and subject device have different dimensions. Both comply with ISO 7176-5:2008 Wheelchairs – Part 5: Determination of dimensions, mass, and maneuverings space so these differences do not affect safety and effectiveness. |
| | Model JJW-7003: 850mm | | |
| Maximum obstacle climbing | 20mm | 15mm | |

Table 2 Safety comparison

| Item | Subject Device | Predicate Device | Results |
| --- | --- | --- | --- |
| Biocompatibility | All user directly contacting materials are compliance with ISO10993 guidance. | All user directly contacting materials are compliance with ISO10993 guidance. | Same |
| Electromagnetic Compatibility (EMC) | ISO7176-21 & IEC 60601-1-2 | ISO7176-21 & IEC 60601-1-2 | Same |
| Performance | ISO7176 series | ISO7176 series | Same |
| Label and labeling | Conforms to FDA Regulatory requirements | Conforms to FDA Regulatory requirements | Same |
| Item | Subject Device | Predicate Device | Results |
| --- | --- | --- | --- |
| ISO7176-1 | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | Same |
| ISO7176-2 | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. | Same |
| ISO7176-3 | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | Same |
| ISO7176-4 | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification. | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification. | Same |

{10}

ZheJiang J&J Mobility Co., Ltd.
#18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

| Item | Subject Device | Predicate Device | Results |
| --- | --- | --- | --- |
| ISO7176-5 | The dimensions, mass has been determined after the testing according to the ISO 7176-5 | The dimensions, mass has been determined after the testing according to the ISO 7176-5 | Same |
| ISO7176-6 | The dimensions, mass has been determined after the testing according to the ISO 7176-6 | The dimensions, mass has been determined after the testing according to the ISO 7176-6 | Same |
| ISO7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7 | Same |
| ISO7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | Same |
| ISO7176-9 | The test results shown that the device under tests could continue to function according to manufacturer’s specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under tests could continue to function according to manufacturer’s specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | Same |
| ISO7176-10 | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | Same |
| ISO7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | Same |
| ISO7176-13 | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | Same |
| ISO7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | Same |
| ISO7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | Same |
| ISO 16840-10 | The performance of resistance to ignition meet the requirements of ISO 16840-10 | The performance of resistance to ignition meet the requirements of ISO 16840-10 | Same |
| ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | Same |

7 of 6

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ZheJiang J&J Mobility Co., Ltd. #18, Baiyang Street, Wuyi, Jinhua City, ZheJiang, China

| Item | Subject Device | Predicate Device | Results |
| --- | --- | --- | --- |
| ISO 7176-22 | The ISO 7176-series performance testing used set-up procedures according to ISO 7176-22 | The ISO 7176-series performance testing used set-up procedures according to ISO 7176-22 | Same |
| ISO 7176-25 | The performance of batteries and chargers for powered wheelchairs meet the requirements of ISO 7176-25 | The performance of batteries and chargers for powered wheelchairs meet the requirements of ISO 7176-25 | Same |

# Substantial Equivalence Discussion

The proposed (subject) 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 7176-22, ISO 7176-25, and 1995 FDA Guidance on 510(k) Submissions for Mechanical and Powered Wheelchairs. The subject device also provided electromagnetic compatibility (EMC) testing according to IEC 60601-1-2 and Enhanced-level software documentation (including verification and validation testing) in accordance with FDA's 2023 Guidance on the "Content of Premarket Submissions for Device Software Functions."

The proposed device performs in a similar manner to the predicate device. All these tests have corresponding requirements/ acceptance criteria following above mentioned standards. And the test results show that the subject device is within acceptable performance specifications and thus 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.

# 3. 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.

# 4. Substantially Equivalency Conclusion

Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate device, K252671 Electric Wheelchair from Hebei Dansong Medical Technology Co., Ltd.