The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors, and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 5 degrees.

Device Description

A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability.

"Nuocande Plastic Manual Wheelchair Model NKD L07" is user propelled, manually operated folding wheelchairs that are indicated for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 5 degrees. Each consists of four wheels, a mechanical frame and nylon upholstery that is ignition resistant.

"Nuocande Plastic Manual Wheelchair Model NKD L07" has a physical dimension of a physical dimension of 1090 (depth) x 730 (width) x 850 (height) mm, with the seat itself has a dimension of 411 (depth) x 447 (width) x 365 (height) mm. The device has a weight capacity of 100 kilograms, and weighs about 19 kilograms. The color is dark yellow.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nuocande Plastic Manual Wheelchair Model NKD L07:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Model NKD L07)
Static Stability (ISO 7176-1:1999)	Meets ISO 7176-1:1999
Effectiveness of Brakes (ISO 7176-3: 2003)	Meets ISO 7176-3: 2003
Static Strength (ISO 7176-8: 1998)	Meets ISO 7176-8: 1998
Impact Strength (ISO 7176-8: 1998)	Meets ISO 7176-8: 1998
Fatigue Strength (ISO 7176-8:1998)	Meets ISO 7176-8:1998
Resistance to Ignition (ISO 7176-16:1997)	Meets ISO 7176-16:1997

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. The tests were performed on the "Nuocande Plastic Manual Wheelchair Model NKD L07" itself. The data provenance is from non-clinical testing conducted according to international standards. The country of origin for the device manufacturing is China (Ningbo, Zhejiang). The study is prospective in the sense that the device was manufactured and then tested to these standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. For a physical device like a wheelchair, "ground truth" is established by adherence to widely accepted engineering and safety standards (ISO standards in this case) through objective measurements and destructive/non-destructive testing, rather than expert consensus on a diagnostic image or clinical finding.

4. Adjudication Method for the Test Set

This information is not applicable, as it pertains to subjective assessments or diagnostic interpretations, which are not relevant for the performance testing of a mechanical wheelchair.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of data (e.g., medical imaging). The current document describes testing of a mechanical device against objective performance standards.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable as the device is a mechanical wheelchair, not an algorithm. The performance evaluation is inherently "standalone" in the sense that it evaluates the physical product's compliance with specified standards, without human interaction influencing the measurement of that compliance (beyond operating the testing equipment).

7. The Type of Ground Truth Used

The "ground truth" used is adherence to international consensus standards for mechanical wheelchairs, specifically various parts of ISO 7176. These standards define objective performance thresholds and testing methodologies that the device must meet to be considered safe and effective for its intended use.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. The current document describes the testing of a manufactured physical product.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" for this type of device submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a group of people. The symbol is composed of three interconnected profiles facing to the right, creating a sense of unity and collaboration.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 25, 2015

Ningbo Lecount Medical Technology Co., Ltd. c/o Charles Shen Manton Business and Technology Services 37 Winding Road Oakland, NJ 07436

Re: K151797

Trade/Device Name: Nuocande Plastic Manual Wheelchair Model NKD L07 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: June 17, 2015 Received: July 2, 2015

Dear Mr. Shen:

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 (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. 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.

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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151797

Device Name

Nuocande Plastic Manual Wheelchair Model NKD L07

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Research Use (Part 21 CFR 361 Subpart D)	Commercially-Oriented Use (21 CFR 361 Subpart C)
-------------------------------------------------------------------	--------------------------------------------------------------------------------------

__ 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.

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Section 5: 510(k) Summary:

This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92

Submitter & Foreign Manufacture Identification

Ningbo Lecount Medical Technology Co., Ltd. 57 Longfei Road, Yunlong Industry Zone, Yingzhou District, Ningbo, Zhejiang, 315135 China Submitter's FDA Registration Number: N/A

US Agent and Contact Person

Charles Shen Manton Business and Technology Services 37 Winding Ridge Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com

Date of Summary: June 01, 2015

Device Name:
Proprietary Name:	"Nuocande Plastic Manual Wheelchair Model NKD L07"
Common Name:	Mechanical Wheelchair
Classification Name:	Wheelchair, Mechanical
Device Classification:	1
Regulation Number:	21 CFR 890.3850
Panel: General	Physical Medicine
Product Code:	IOR

Predicate Device Information:

(1) K132257, "Manual Wheelchair Model SY100-MA02A", manufactured by "Zhejiang Jiafeng Electrical & Mechanical Co., Ltd"

Device description:

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Intended Use:

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 5 degrees.

Comparison to Predicate Devices

"Nuocande Plastic Manual Wheelchair Model NKD L07" manufactured by "Ningbo Lecount Medical Technology Co., Ltd." is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

(1) K132257, "Manual Wheelchair Model SY100-MA02A", manufactured by "Zhejiang Jiafeng Electrical & Mechanical Co., Ltd"

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The following table shows similarities and differences of use, design, and material between our devices and the predicate device.

Description	Subject Devices	Predicate Device (K132257), ModelSY 100-MA02A
Indication forUse	The device is intended for medicalpurposes to provide mobility to personsrestricted to a sitting position. It is designedfor use indoors and outdoors, over smoothsurfaces (all standard indoor flooringsurfaces, concrete, asphalt and pocked dirt)that are free of large obstacles and inclinesgreater than 5 degrees.	The device is intended for medicalpurposes to provide mobility topersons restricted to a sittingposition. It is designed for useindoors and outdoors, over smoothsurfaces (all standard indoorflooring surfaces, concrete, asphaltand pocked dirt) that are free oflarge obstacles and inclines greaterthan 8 degrees.
Basic Design	Four wheels, a plastic frame and a textileneupholstery that is flame resistant.	Four wheels, a metal frame and anylon upholstery that is flameresistant.
Materials	Steel (wheel rim and caster rim), hard plastics(Frame), and flame resistant fabrics (seat)	Steel (frame) and flame resistantfabrics (seat)
Powder	Mechanical	Same
Dimension	1090 x 730 x 850 (depth x width x height)	1025 x 661 x 920 mm (depth xwidth x height)
Armrest	Non Flip Back/Non Height Adjustable	Non Flip Back/Height Adjustable
Rear Axle	Offset Axle, Quick Release Axle	Same
Back Wheel	58.5 cm (=23 inch)	61 cm (=24 inch)
Casters	8 inch	8 inch
Wheel Lock	Pull to Lock	Same
WeightCapacity	100 Kg	130 Kg
Weight	19 Kg	16.5 Kg
Color	Yellow	Dark Green
Description	Subject Device	Predicate Device (K132257)
Static Stability	Meets ISO 7176-1:1999	Meets ISO 7176-1:1999
Effectiveness ofBrakes	Meets ISO 7176-3: 2003	Meets ISO 7176-3: 2003
Static Strength	Meets ISO 7176-8: 1998	Meets ISO 7176-8: 1998
Impact Strength	Meets ISO 7176-8: 1998	Meets ISO 7176-8: 1998
Fatigue Strength	Meets ISO 7176-8:1998	Meets ISO 7176-8:1998
Resistance toIgnition	Meets ISO 7176-16:1997	Meets ISO 7176-16:1997

Table 5.1: Comparison of Intended Use, Design, and Material

Our devices and the predicate device are almost identical in terms of all areas described in the above table (Table 5.1). There are some minor differences with the predicate device don't affect the safety or effectiveness of the subject device.

The following table shows similarities and differences of the performance between our devices and the predicate device. Tests were conducted following the recommended

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procedures outlined in the respective consensus standards, and results for "Nuocande Plastic Manual Wheelchair Model NKD L07'' met all relevant requirements in the test standards, our internal specifications, and are comparable to the predicate device.

Table 5.2: Comparison of Performance Testing

The tests were performed following the general requirements outlined in ISO 7176-11: 2012, 7176-13: 1989. The product labeling conforms to requirements of 7176-15: 1996.

A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:

"Nuocande Plastic Manual Wheelchair Model NKD L07" meets performance requirements per ISO 7176-1:1999, ISO 7176-3: 2003, ISO 7176-8: 1998, ISO 7176-11: 2012, 7176-13: 1989, 7176-15: 1996 and ISO 7176-16:1997. They are safe and effective, and their performances meet the requirements of their pre-defined acceptance criteria and intended uses.

A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.

Clinical data is not needed for manual wheelchair cleared by the 510(k) process.

Substantial Equivalent Conclusions

Based on the comparison of intended use, design, materials, and performance, our "Nuocande Plastic Manual Wheelchair Model NKD L07" is substantial equivalent to their predicate devices.

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).