K Number
K241379
Device Name
Powered Wheelchair (NXN20-205, NXN20-205M)
Date Cleared
2024-09-16

(124 days)

Product Code
Regulation Number
890.3860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device 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 Description
The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The NXN20-205 and NXN20-205M Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position. The Powered Wheelchair has 7 inch front wheel and 12 inch rear tire. The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A. Max. loading can not be over than 110Kgs. Max. distance of travel on the fully charged battery is 16km and Max. speed forward is 5.5km/h. The braking time is about 2s, and the braking distance is ≤790m.
More Information

Not Found

No
The description details a standard powered wheelchair with a joystick control and electric motor, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Yes
The device is described as providing mobility to disabled or elderly individuals, which addresses a health-related limitation and improves their well-being, aligning with the definition of a therapeutic device.

No

The device description clearly states its purpose is to "provide mobility to a disabled or elderly person limited to a seated position." There is no mention of it being used to diagnose any medical condition; it is a transportation vehicle.

No

The device description clearly outlines numerous hardware components including a motor, batteries, frame, wheels, and a control panel, indicating it is a physical device with integrated software, not a software-only device.

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 human body.
  • Device Description: The description details a powered wheelchair with components related to transportation and mobility (motor, battery, wheels, joystick, etc.). There are no components or functions related to analyzing biological samples.
  • Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analysis of biological samples (blood, urine, tissue, etc.)
    • Detection or measurement of analytes
    • Diagnostic purposes (identifying a disease, condition, or state)
    • Use in a laboratory or clinical setting for diagnostic testing

The device is clearly a medical device intended for mobility assistance, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

The device 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 subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed.

The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.

The NXN20-205 and NXN20-205M Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position.

The Powered Wheelchair has 7 inch front wheel and 12 inch rear tire.

The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A.

Max. loading can not be over than 110Kgs.

Max. distance of travel on the fully charged battery is 16km and Max. speed forward is 5.5km/h.

The braking time is about 2s, and the braking distance is

§ 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).

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

September 16, 2024

Zhejiang Nysin Medical Co., Ltd. % Boyle Wang Manger Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China

Re: K241379

Trade/Device Name: Powered Wheelchair (NXN20-205, NXN20-205M) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 3, 2024 Received: September 3, 2024

Dear Boyle Wang:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality 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,

Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241379

Device Name

Powered Wheelchair (NXN20-205, NXN20-205M)

Indications for Use (Describe)

The device 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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

K241379

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

1.0 Submitter's information

Name: Zhejiang Nysin Medical Co., Ltd. Address: Building 13, No. 305 Jiulong North Road, Dongcheng District, Yongkang, Jinhua City, Zhejiang Province, China Tel: +86-579-87153722/ +86-18969388822 Contact: Zhang Xiaoying

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

Date of Preparation: Sep.02,2024

2.0 Device information

Trade name: Powered Wheelchair Common name: Powered Wheelchair Classification name: Powered Wheelchair Model(s): NXN20-205, NXN20-205M

3.0 Classification

Production code: ITI Regulation number: 21 CFR 890.3860 Classification: Class II Panel: Physical Medicine

4.0 Predicate device information

Manufacturer: Kunshan Aoshida Electric Technology Co., Ltd. Trade/Device: A08 Power Wheelchair

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510(k) number: K163204

5.0 Indication for Use Statement

The device 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.

6.0 Device description

The subject device, Powered Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed.

The Powered Wheelchairs consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.

The NXN20-205 and NXN20-205M Powered Wheelchair is intended to provide mobility to a disabled or elderly person limited to a seated position.

The Powered Wheelchair has 7 inch front wheel and 12 inch rear tire.

The motor of electric wheelchair is DC24V 200W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/3A.

Max. loading can not be over than 110Kgs.

Max. distance of travel on the fully charged battery is 16km and Max. speed forward is 5.5km/h.

The braking time is about 2s, and the braking distance is ≤790m.

7.0 Summary of Non-Clinical Testing

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability

ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electrically powered 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 overall dimensions, mass and manoeuvring 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

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ISO 7176-8 : 2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths

ISO 7176-9: 2009 Wheelchairs - Part 9: Climatic tests for 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 : 2008 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 7176-21 : 2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers

ISO 7176-22 : 2014 Wheelchairs - Part 22: Set-up procedures

ISO 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs

ISO 16840-10: 2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method

IEC 60601-1-2:2020 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

Software Verification and Validation Testing

Software documentation including verification & validation was provided in accordance with FDA Guidance: Content of Premarket Submissions for Device Software Functions for software.

The Software Validation is in compliance with FDA Guidance.

8.0 Summary of Clinical Testing

No clinical study implemented for the electric wheelchair.

9.0 Technological Characteristic Comparison Table

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ItemProposed devicePredicate deviceRemark
Product CodeITIITISame
Regulation No.21 CFR 890.386021 CFR 890.3860Same
ClassIIIISame
Product namePowered WheelchairA08 Power Wheelchair-
510(k) No.K241379K163204-
ModelsNXN20-205
NXN20-205MA08-
Intended UseThe device is a motor driven, indoor and outdoor transportation vehicle with the intended use toIt is a motor driven, indoor and outdoor transportation vehicle with the intended useSame
provide mobility to a disabled or elderly person limited to a seated position.to provide mobility to a disabled or elderly person limited to a seated position.
Use environmentIndoor and outdoor useIndoor and outdoor useSame
Patient
PopulationThis product is suitable for
disabled people with mobility
difficulties and elderly people.This product is suitable for
disabled people with mobility
difficulties and elderly people.Same
Product structureConsist of two foldable armrests,
a backrest, a seat cushion, a
safety belt, a foldable frame, two
rear driving wheels with hub
motor/electromagnetic brake
assemblies, two pivoting casters,
two Li-ion batteries, an off-board
battery charger, a control panel,
and an electric motor controller.Consists primarily of a
foldable welded-aluminum
frames, two sealed transaxle
motors drive system,
electromagnetic braking
system, electric motor
controller and two Li-ion
batteries with an off-board
battery charger.Similar
Driving systemDirect drive on the rear wheelsDirect drive on the rear
wheelsSame
Movement control
methodBy Joystick controlBy Joystick controlSame
Number of
wheels44Same
Brake systemAutomatic electromagnetic
brake systemElectromagnetic
brake systemSame
Main frame
materialModel NXN20-205 consists
of Aluminum alloy, and
model NXN20-205M consist
with Magnesium alloy.Welded-aluminumSame
MotorBrushless motor,
DC24V* 200W*2pcsBrushless motor,
24 VDC *250W * 2 pcsMinor differences in the
BatteryDC 24V 12Ah Lithium-ion, 2 pcsLithium-ion
20 Ah x 24 VDCdimensions will not
impact the safety and
Off-board chargerOff-board chargereffectiveness of the
Battery chargerInput: 100-240 VAC
Output: DC 24V, 3AInput: 110-240 VAC
Output: DC 24V, 2 Ampsubstantial equivalence.

Table1-General Comparison

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Table2 Performance Comparison

ItemSubject DeviceSubject DevicePredicate DeviceRemark
ModelNXN20-205NXN20-205MA08--
Overall length980mm960mm890 mm
Overall width580mm580mm603 mmMinor differences in the
Stowage
length690mm650mm324 mmdimensions will not
impact the safety and
Stowage width250mm250mm603 mmeffectiveness of the
substantial equivalence.
Stowage
height720mm740mm670 mm
Weight, w/
Battery42.5 lbs. /19.3 kg40.33 lbs. /18.3 kg61.7 lbs. /28 kgThe difference will
not raise any new safety
and effectiveness
concerns.
Front
wheel(inch)7
(PU solid tire)8
(PU solid tire)Smaller sizes of font wheels
Rear tire (inch)12
(PU solid tire)10
(PU solid tire)Larger sizes of rear wheels
bring steadier pivoting
function than predicate
device.
Cruising
Range(km)1620The 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.
Obstacle
climbing(mm)2540The smaller height in the
obstacle climbing will not
impact the safety and
effectiveness of the subject
device.
Static stabilityNot publicly availableBoth of the devices are
forward
Static stability
rearwardevaluated according to standard ISO 7176-1:2014, so the different static stability will not impact the safety and effectiveness
Static stability
sideways
Max. loading
(kg)242.5lbs(110kg)220 lbs (100 kg)More loading weight means more convenient for the transportation
Min. Turning
radium810mm800mmSame
Minimum
braking
distance0.79m1mSimilar
Max Speed
Forwards1.53m/s (5.5 km/h)1.94m/s (7 km/h)The devices are evaluated according to standard ISO 7176-6:2018, so the different will not impact the safety and effectiveness
Max. Speed
Backward0.8m/s (2.88 km/h)Not publicly availableThe devices are evaluated according to standard ISO 7176-6:2018, so the different will not impact the safety and effectiveness
ControllerYanteon Mechanical & Electronic Technology (Shanghai) Co. Ltd.
Joystick Y2450M
Controller Y2430MYisheng Electric Co. Ltd ,
WS-1, 40ADifferent
Although different controller is used, both the control system, including the joystick controller, the electromagnetic brakes and the user interface are similar. The joystick controls the directions and speed of movement, and when the joystick is released, the powered wheelchair will slow down to stop and the brakes will automatically re-engage. The controller also provides the battery status displaying and abnormal condition displaying. Both of the control systems are evaluated according to standard ISO 7176-14:2008 and software
validation requirement and
there are no new safety and
effectiveness concerns due
to the difference.
Speed control
methodJoystick control methodJoystick control methodSame

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10

Table3 Safety Comparison

ItemProposed DevicePredicate DeviceRemark
Materials
contacting userArmrest: PU;
Backrest/Seat: Sandwich mesh
fabric (polyester)
Seat belt: Nylon
Controller Housing:ABS
Joystick: Silicone
Button:SiliconeArmrest: PU;
Backrest/seat cushion: PU foam
covered by nylon fabric clothBiocompatibility evaluation
has been carried out per
ISO 10993-1. There are no
new safety and
effectiveness concerns due
to the difference.
Biocompatibility
of materials
contacting userComply with FDA GuidanceComply with ISO 10993-1, FDA
Guidance, Tests included
Cytotoxicity (ISO 10993-5:2009),
Sensitization and Intracutaneous
Reactivity (ISO 10993-10:2010)Same

Summary of substantial equivalence discussion:

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. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

10.0 Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device under K163204.