Electric wheelchair (NSDS-01)

K252671 · Hebei Dansong Medical Technology Co., Ltd. · ITI · Nov 3, 2025 · Physical Medicine

Device Facts

• Record ID: K252671
• Device Name: Electric wheelchair (NSDS-01)
• Applicant: Hebei Dansong Medical Technology Co., Ltd.
• Product Code: ITI · Physical Medicine
• Decision Date: Nov 3, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

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

Electric wheelchair (NSDS-01) is a battery-powered, four-wheeled mobility vehicle for adult use. User operates device via joystick controller to manage speed and direction; joystick movement from center determines speed; releasing joystick triggers automatic braking. Device features manual mode lever for assistant-assisted pushing and quick-assembly/disassembly structure for storage. Powered by DC motor and lithium-ion battery. Safety features include anti-tip wheels and electromagnetic braking system (solenoid brake locks motor upon power disconnect). Used in indoor and outdoor environments by patients with mobility limitations. Healthcare providers or caregivers do not directly operate the device during standard use, but the device facilitates patient independence.

Clinical Evidence

No clinical or animal studies were performed. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993), EMC (ISO 7176-21, IEC 60601-1-2), and performance testing per the ISO 7176 series (stability, braking, energy consumption, obstacle climbing, and durability).

Technological Characteristics

Aluminum alloy frame; 8-inch front/12.5-inch rear wheels with PU foam tires; 24V 250W brushed DC motor; 25.55V 13Ah lithium-ion battery; joystick-controlled electronic braking system. Dimensions: 1100x650x960 mm. Complies with ISO 7176 series for powered wheelchairs.

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 (K240913)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

November 3, 2025

Hebei Dansong Medical Technology Co., Ltd.
% Kiwi Xu
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Century Ave.
Shanghai, 200122
China

Re: K252671
Trade/Device Name: Electric wheelchair (NSDS-01)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: August 25, 2025
Received: August 25, 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.

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"

{1}

K252671 - Kiwi Xu
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 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-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).

{2}

K252671 - Kiwi Xu
Page 3

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

{3}

| 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. | K252671 | ? |
| Please provide the device trade name(s). | | ? |
| Electric wheelchair (NSDS-01) | | |
| 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 (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

{4}

# 510k summary

Date:2025.8.13

## Submitter:

Name: Hebei Dansong Medical Technology Co., Ltd.

Address: No. 1 Business Office Building, Donghua Guoyue

Mansion, No.89, East Second Ring South Road, Yuhua District,

Shijiazhuang City, Hebei Province, China

Contact: Wendy Zhang

Email: [e-mail]

## Device:

510Knumber: K252671

Device Name: Electric Wheelchair

Model: NSDS-01

Classification name: Powered wheelchair

Regulation class: 2

Regulation number: 21CFR 890.3860

Panel: Physical Medicine

Product code: ITI

## Predicate device:

510Knumber: K240913

Device Name: Electric Wheelchair

Model: HBLD3-B, HBLD3-E

Shanghai Hubang Intelligent Rehabilitation Equipment 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 lithium-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel

{5}

(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 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.

The Electric Wheelchair has 8 inch front wheel and 12.5 inch rear tire.

Max. distance of travel on the fully charged battery is 11 km and Max. speed forward is 6.48 km/h.

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 2s, and the braking distance is ≤1.5m.

## 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.

## Product Parameter

Table 1 General Comparison

| Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark |
| --- | --- | --- | --- |
| Manufacturer | Hebei Dansong Medical Technology Co., Ltd. | Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd | - |
| Common or Usual name | Power Wheelchair | Power Wheelchair | Same |
| Model(s) | NSDS-01 | HBLD3-B, HBLD3-E | -- |

{6}

| Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark |
| --- | --- | --- | --- |
| 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 |
| 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 |
| 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 | ≤1.5 m | ≤1.5 m | Same |
| Maximum safe operational incline degree | 6° | 6° | |
| Armrest | Polyurethanes (PUR) | ABS | Analysis: Difference of the materials will not raise safe and effectiveness concerns. The biocompatibility evaluation have been conducted to verify the safety and effectiveness of the material. |
| Battery charger | Off-board charger Input: 220V, 50Hz, 88W, Output: 24 V-29.9V, 3A; | Off-board charger Input: 100-240V, 50/60Hz, 1.5A, Output: 24 Vdc, 2A; | Analysis: Minor differences in the dimensions will not impact the safety and effectiveness |
| | on the battery charger | | |
| Battery charge | Off-board charge Input: 220V, 50Hz, 88W, Output: 24 V-29.9V, 3A; | Off-board charge Input: 100-240V, 50/60Hz, 1.5A, Output: 24 Vdc, 2A; | Analysis: Minor differences in the dimensions will not impact the safety and effectiveness |

{7}

| Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark |
| --- | --- | --- | --- |
| | | | of the substantial equivalence. |
| Main frame material | Aluminum alloy | Aluminum Alloy | Same |
| Seat cushion | Nylon | Polyester fabric | **Analysis:** Difference of the materials will not raise safe and effectiveness concerns. The biocompatibility evaluation have been conducted to verify the safety and effectiveness of the material. |
| Back cushion | Nylon | Polyester fabric | |
| Overall Dimension (length*width*height) | 1100×650×960 mm | HBLD3-B model: 960×580×890 mm
HBLD3-E model: 1090×640×900 mm | **Analysis:** Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. |
| Folded Dimension (length*width*height) | 810×430×650 mm | HBLD3-B model: 890×600×380 mm
HBLD3-E model: 730×350×950 mm | |
| Front wheel size/type | 8"/ Poly -edge PU foam | 7" x 1.75"/PU Solid tire | **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. |
| Rear wheel size/type | 12.5" x 2.25"/ Poly -edge PU foam | 12" x 2.125" pneumatic tire | |
| Max speed forward | 6.48 km/h(1.8 m/s) | 6-8 km/h (1.6-2.2 m/s), adjustable | **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. |

{8}

| Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark |
| --- | --- | --- | --- |
| Max Speed backward | Less than 3 km/h (0.8m/s) | Less than 3 km/h (0.8m/s) | Same |
| Max loading weight | 150 kg | 100 kg | **Analysis:**
The subject device complies with ISO 7176 series test. The test report can prove that this maximum load capacity is safe. |
| Battery | 25.55V 13Ah Lithium-ion battery | Li-ion battery pack; rechargeable, 24 V DC 5.2 Ah*2 | **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. |
| Maximum distance of travel on the fully charged battery | 11 km | 20km | **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. |
| Motor | Brushed DC motor; 24V; 250W | Brushless DC motor; 24VDC; 150W; 2pcs | **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 |
| Turning Radius | 975mm | HBLD3-B model: 875 mm
HBLD3-E model: 1050 mm | **Analysis:**
The predicate device and |

{9}

Table 2 Safety comparison

| Item | Proposed Device | Predicate Device | Results |
| --- | --- | --- | --- |
| Biocompatibility | All user directly contacting materials are compliance with ISO10993 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | Same |
| 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 | Conforms to FDA Regulatory | Same |
| Item | Proposed 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 |
| 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 |

{10}

| Item | Proposed Device | Predicate Device | Results |
| --- | --- | --- | --- |
| 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 |
| ISO7176-16/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 |

## Substantial Equivalence Discussion:

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 and FDA guidance Submission for Power Wheelchair.

{11}

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.

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.

## 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.

## Substantially Equivalency Conclusion:

Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate devices, K240913 Power Wheelchair from Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd.