(90 days)
Not Found
No
The description focuses on mechanical and electronic components for basic mobility control (joystick, motor, battery) and does not mention any features or performance metrics indicative of AI/ML. The performance studies are standard for medical devices and do not suggest AI/ML evaluation.
Yes
The device is described as a transportation vehicle intended to provide mobility to a disabled or elderly person, which is a therapeutic purpose.
No
Explanation: The device is described as a motor-driven transportation vehicle designed to provide mobility for disabled or elderly individuals. Its functions relate to movement, adjustments for user comfort, and power systems. There is no mention of it being used to detect, diagnose, monitor, treat, or prevent any disease or condition. The performance and testing focus on safety, stability, durability, and functional operation as a mobility aid, not on diagnostic capabilities.
No
The device description clearly outlines numerous hardware components including a frame, wheels, seat, armrest, battery, motor, and controller. The performance studies also focus on the physical characteristics and safety of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to a disabled or elderly person. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical and electrical device for transportation. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological material. There is no mention of detecting diseases, conditions, or physiological states through in vitro analysis.
- Performance Studies: The performance studies focus on the physical and electrical performance of the wheelchair (stability, braking, strength, etc.), not on the accuracy or reliability of a diagnostic test.
In summary, this device is a mobility aid, not a diagnostic tool.
N/A
Intended Use / 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.
Product codes
ITI
Device Description
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The entire wheelchair can be disassembled, making it easy to carry. The wheelchair comes equipped with an electronically controlled rising seat that allows the user 280mm/11" of seat height adjustment using the joystick.
The armrest can be flipped upside down, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.
The wheelchair uses lead-acid Battery as its power source. The controls the drive leftright motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is carbon steel. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.
When in use, the operator drives the motor of the rear wheel by operating the controller joystick 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 136KG. Only for one person sit.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Product Material Safety: Biocompatibility testing was done according to ISO10993-5, ISO 10993-10, and ISO 10993-23. The test results indicate the material is safe and meets requirements.
Performance of the products: Performance data provided to verify the subject device met all design specifications and supported substantial equivalence. This included a Risk Analysis in accordance with ISO 14971:2019, Software validation, and compliance with various ISO 7176 series standards (ISO 7176-1, -2, -3, -4, -5, -6, -7, -8, -9, -10, -11, -13, -14, -15, -21, -22, -25), ISO 16840-10, and Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020. Key results indicate compliance with these standards, supporting the substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 26, 2025
Kunshan Hi-Fortune Health Products Co., Ltd % Ariel Xiang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K244003
Trade/Device Name: Electrically powered wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 3, 2025 Received: February 26, 2025
Dear Ariel Xiang:
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.
1
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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatory
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Electrically powered wheelchair
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(K) Summary K244003
Document Prepared Date: 2025/2/26
Applicant A.
Kunshan Hi-Fortune Health Products Co., Ltd Address:NO.625 Juxiang Road, Zhangpu Town,Kunshan City, Jiangsu, 215321, CHINA Contact Person: zhanli.Tian Email:zhanli.tian@hi-fortune.net
Submission Correspondent: Primary contact: Ms.Ariel Xiang Title: Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: shouqiu.xiang@sungoglobal.com
Secondary contact: Eva Li Title: Technical Director Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com
B. Device
Trade Name: Electrically powered wheelchair Common Name: Powered wheelchair Models: HP330
Regulatory Information Classification Name: Powered wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine
Predicate device C.
510Knumber: K240105 Device Name:Navigator, Navigator XL
5
Company:Forcemech International LLC
D. Indications for use of the device
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.
ші Device Description:
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design.The entire wheelchair can be disassembled, making it easy to carry. The wheelchair comes equipped with an electronically controlled rising seat that allows the user 280mm/11" of seat height adjustment using the joystick.
The armrest can be flipped upside down, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.
The wheelchair uses lead-acid Battery as its power source. The controls the drive leftright motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is carbon steel. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.
When in use, the operator drives the motor of the rear wheel by operating the controller joystick 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 136KG. Only for one person sit.
ட் Comparison with predicate Device
Table 1 General Comparison
| Elements of
Comparison | Proposed Device | Predicate Device
(K240105) | Remark |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Kunshan Hi-Fortune Health
Products Co., Ltd | Forcemech International LLC | -- |
| Common or Usual name | Electrically powered
wheelchair | Power wheelchair | -- |
| Model(s) | HP330 | FMNVG15, FMNVX06 | -- |
| Classification | Class II | Class II | Same |
| Classification regulation | 21 CFR890.3860 | 21 CFR890.3860 | Same |
| Product code | ITI | ITI | Same |
| 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 | It is a motor driven,
indoor and outdoor
transportation vehicle
with the intended use to
provide mobility to a
disabled or elderly | S.E. |
| | person limited to a
seated position. | person limited to a
seated position. | |
| Use condition | indoor and outdoor use | indoor and outdoor use | S.E |
| Number of wheels | 6, including two front wheels and two rear wheels, two anti-tip wheels | 4,including two front wheels and two rear Wheels | S.E |
| 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 | S.E |
| Movement control
method | By Joystick control | By Joystick control | S.E |
| Driving system | Direct drive on the rear
wheels | Direct drive on the rear
wheels | S.E |
| Brake system | Automatic electromagnetic
brake system | Automatic electromagnetic
brake system | S.E |
| Braking distance | ≤1.5 m | ≤1.5 m | S.E |
| Armrest | Polyurethane | Polyurethane | S.E |
| Max loading weight | 136kg | 120kg | Similar,All safety and
performance have
been validated with
the maximum rated
weight dummy. |
| Maximum safe
operational incline
degree | 6° | 6° | S.E |
| Back cushion | Polyurethane | Polyurethane | S.E |
| Seat cushion | Polyurethane | Polyurethane | S.E |
| Main frame material | Carbon steel material | Aluminum Alloy | Similar,Different
materials will not
affect safety and
performance of the
subject device as all
related stability tests
are performed
according to
standard ISO 7176
series |
| Overall Dimension
(lengthwidthheight) | 950mm660mm950mm | Navigator FMNVG15 Model:
980600940mm
Navigator XL FMNVX06
Model: 980620940mm | Minor difference on
wheelchair
dimension will not
cause different
performance. All
safety and |
| Folded Dimension
(lengthwidthheight) | 740mm600mm410mm | 590mm370mm787mm | performance have
been validated with
the maximum rated
weight dummy. |
| Front wheel size/type | 6" PU Solid tire | 8" (203mm)
Non-Pneumatic tire | Different sizes and
materials will not
affect safety and |
| Rear wheel size/type | 10"PU Solid tires | 11.8" (300mm) Non-
Pneumatic tire | performance of the
subject device as all
related stability tests
are performed
according to
standard ISO 7176
series. |
| Max speed forward | Up to 5.4km/h (1.5m/s) | Up to 6 km/h (1.6 m/s)
adjustable | Similar |
| Max Speed backward | Less than 2.5km/h (0.7m/s) | Less than 3 km/h (0.8 m/s) | Similar |
| Maximum distance of
travel on the fully
charged battery | 12km | 16km | Similar , it will not
cause new safety
and effectiveness
concerns. |
| Battery | Lead-acid
Battery; rechargeable;
12V 22AH | Li-ion battery
pack; rechargeable, 24 VDC
6Ah*2 | Both meet the
requirements of the |
| Battery charger | Off-board charger
Input:100-240VAC,50-
60Hz, 1.2-0.5A
Output:24V,2A | off-board charger
Input: 100-240V. 50/60Hz,
1.5A.
Output: 24 VDC. 2A | ISO 7176-25.It will
not cause new safety
and effectiveness
concerns. |
| Motor | Brushless DC motor;
24VDC; 250W;
2pcs | Brushless DC motor;
24VDC; 250W;
2pcs | S.E |
| Electronic controller | Dynamic,
DLX-REM210-A,
24V | Dual Core Twin Drive
controller | Both meet the
requirements of the
ISO 7176-14.It will
not cause new safety
and effectiveness
concerns. |
| Turning Radius | 825mm | 1200mm | Minor difference in
turning radius is
caused by different
size of wheelchair
and may |
| Min obstacle
climbing | 25mm | 40mm | Minor difference on
obstacle climbing will
not cause new safety
and effectiveness |
6
7
8
| concerns. | |||
|---|---|---|---|
Table 2 safety comparison
| Item | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| Biocompatibility | All user directly contacting | ||
| materials are compliance with | |||
| ISO10993-5、 | |||
| ISO10993-10 and ISO10993-23 | |||
| requirements. | All user directly contacting | ||
| materials are compliance with | |||
| ISO10993-5 and | |||
| ISO10993-10 requirements. | SE | ||
| EMC | IEC 60601-1-2&ISO7176-21 | IEC 60601-1-2&ISO7176-21 | SE |
| Performance | ISO7176 series | ISO7176 series | SE |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | SE |
G. 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, ISO 7176-25, and FDA guidance Submission for Power Wheelchair.
The indications for use for both devices are the same. The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14. Software validation is carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3.
The frame materials,Turning radius, Maximum obstacle climbing and Maximum loading weight are slightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-8,ISO 7176-10 and ISO 7176-11.
The biocompatibility of the predicate device and proposed device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2021 & ISO 10993-23: 2021.
The flame-retardant test of the seat cushion/ backrest of both subject device and predicate device is carried out according to the ISO 16840-10 test. Therefore, both devices are assured to be under the same safety level.
In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
H. Product Performance
a) Product Material Safety
To ensure the safety of the wheelchair material, the bio-compatibility testing was done to the products. The testing was conducted according to the following standards: ISO10993-5 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
9
From the test result, we can find the material are safety and can meet the requirements.
b) Performance of the products
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination. Risk Analysis developed in accordance with ISO 14971: 2019.
Software validation
ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric 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 dimensions, mass and maneuvering 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 strength
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 7176-14:2022 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 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters
ISO 7176-22: 2014 Wheelchairs-Part 22: Set-up proceduresd
ISO 7176-25: 2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs. Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020.
l. Conclusion
The proposed device and predicate device have the same technological characteristics, features, specifications, materials, mode of operation, and intended use of the device. To ensure all the key characteristic of the products can meet the requirements, the testing was done and all the results indicate the positive conclusion.
Based on the analysis above, we confirm these two products are substantially equivalent.