(54 days)
Not Found
No
The description details a purely mechanical, manually operated wheelchair with no mention of any computational or intelligent features.
Yes
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position due to illness, injury, or disability, which aligns with the definition of a therapeutic device.
No
The device is a manual wheelchair, which is a mobility aid designed to provide independent mobility for individuals unable to walk. It does not perform any diagnostic functions like analyzing patient data, detecting diseases, or evaluating medical conditions.
No
The device description explicitly details a physical, mechanical wheelchair with a frame, wheels, and upholstery, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device's Intended Use: The intended use of the "Nuocande Plastic Manual Wheelchair Model NKD L07" is clearly stated as providing mobility to persons restricted to a sitting position. It is a physical aid for movement.
- Device Description: The description details a mechanical chair with wheels for transportation, not a device for analyzing biological samples.
- Lack of IVD-related information: The document does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.
The information provided describes a medical device used for physical support and mobility, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for 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.
Product codes
IOR
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.
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)
Tests were conducted following the recommended 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.
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.
"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.
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
§ 890.3850 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).
0
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
1
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)
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.
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)
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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:
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.
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"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.
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), Model
SY 100-MA02A |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
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. | 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 8 degrees. |
| Basic Design | Four wheels, a plastic frame and a textilene
upholstery that is flame resistant. | Four wheels, a metal frame and a
nylon upholstery that is flame
resistant. |
| Materials | Steel (wheel rim and caster rim), hard plastics
(Frame), and flame resistant fabrics (seat) | Steel (frame) and flame resistant
fabrics (seat) |
| Powder | Mechanical | Same |
| Dimension | 1090 x 730 x 850 (depth x width x height) | 1025 x 661 x 920 mm (depth x
width 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 |
| Weight
Capacity | 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 of
Brakes | 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 to
Ignition | 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
6
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.