(69 days)
Not Found
Not Found
No
The document describes a standard wheelchair with a drive unit and explicitly states that mentions of AI, DNN, or ML were "Not Found".
No
A wheelchair is a mobility device, not a therapeutic device, as its primary function is to provide transportation for individuals with mobility impairments, not to treat a disease or condition.
No
The device is a wheelchair and drive system intended to provide mobility for physically challenged individuals. Its function is to assist movement, not to diagnose medical conditions.
No
The device description explicitly states that the device comprises a wheelchair and a drive unit, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a wheelchair to provide mobility for physically challenged persons. This is a mechanical aid for mobility, not a device used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical components of a wheelchair and a drive unit. There is no mention of analyzing biological samples or performing any diagnostic tests.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Using reagents or assays
The device is a medical device, specifically a mobility aid, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended devices comprises a wheelchair. The wheelchair empowers physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
The intended use of the device is as a wheelchair. The wheelchair and drive system empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The MyCycle Handmaster Victory wheelchair comprises a wheelchair and a drive unit for powering the wheelchair. The wheelchair comprises a substantially identical device as the Quickie 2hp Titanium Wheelchair. The measurements of each dimension, as well as the construction materials, and the type of welding techniques utilized are substantially identical. based on the documentation available to applicant regarding this wheelchair. The only difference is that the MyCvcle device is not of Titanium but of conventional metal materials. However, the maximum weight bearing capacity, the tiltover testing, the dimensions and the weight of the device are identical.
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
all ages
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)
Testing: Inasmuch as the device is substantially identical in every dimension to the Quickie 2hp Titanium Wheelchair, the same test results that are exhibited by the Quickie 2hp Titanium Wheelchair are applicable to the MyCycle Handmaster Light Wheelchair.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Quickie 2hp Titanium Wheelchair, Wijit manual power attachment
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
1981557
Section III -- Summarv under 21 CFR 807.92
- Submitter: Richvale Ltd d/b/a MyCycle 885 N. LaSalle Street Chicago, Illinois 60610 (312) 867-7065 (312) 867-7068 Goran Rajsic
Date: April 30, 1998
Name of the device: MyCycle Handmaster Victory Wheelchair
Identification of predicate device: Quickie 2hp Titanium Wheelchair and Wijit manual power attachment
Description of the device: The MyCycle Handmaster Victory wheelchair comprises a wheelchair and a drive unit for powering the wheelchair. The wheelchair comprises a substantially identical device as the Quickie 2hp Titanium Wheelchair. The measurements of each dimension, as well as the construction materials, and the type of welding techniques utilized are substantially identical. based on the documentation available to applicant regarding this wheelchair. The only difference is that the MyCvcle device is not of Titanium but of conventional metal materials. However, the maximum weight bearing capacity, the tiltover testing, the dimensions and the weight of the device are identical.
Intended use of the device: The intended devices comprises a wheelchair. The wheelchair empowers physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
Comparison of device characteristics to predicate: This device has similar technological characteristics as the predicate devices. It utilizes the same manufacturing techniques and materials for the
1
construction of the wheelchair itself. In addition, it utilizes a drive system which under the FDA definitions is a substantially equivalent device.
-
Testing: Inasmuch as the device is substantially identical in every dimension to the Quickie 2hp Titanium Wheelchair, the same test results that are exhibited by the Quickie 2hp Titanium Wheelchair are applicable to the MyCycle Handmaster Light Wheelchair.
510(k) number: not assigned at the time of writing of the summary. -
Conclusion: The MyCycle Handmaster Victory Wheelchair is substantially equivalent to the predicated devices listed in this 510(k) and the technology and construction of the device does not raise any new issues of safety and effectiveness.
2
Image /page/2/Picture/0 description: The image shows a black circle on a white background. The circle is solid black and appears to be slightly irregular in shape, with some minor imperfections along its edges. The white background is plain and provides a stark contrast to the black circle, making it stand out prominently. The image is simple and minimalist, focusing solely on the contrast between the two colors and the shape of the circle.
Device Descriptive Information Section II.
Intended Use
Section A.
The intended devices comprises a wheelchair. The wheelchair empowers physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ਹੈ ਰਿਰੋਰ JUL
Ms. Susan Mays Managing Director Richvale Limited 120 East 87th Street Suite P8I New York, New York 10128
Re : K981557 MyCycle, Handmaster, Victory Trade Name: K981558 Trade Name: MyCycle, Handmaster, Light Regulatory Class: I Product Code: IOR Dated: April 30, 1998 Received: May 1, 1998
Dear Ms. Mays:
We have reviewed your Section 510 (k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note:
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Page 2 - Ms. Susan Mays
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
5
Date: July 1, 1998
Re: K981557 MyCycle Handmaster Victory
Indications for Use: (Intended Use:)
The intended use of the device is as a wheelchair. The wheelchair and drive system empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 1