(29 days)
Tarsys Tilt and Recline System
Not Found
No
The summary describes a power tilt and recline system for wheelchairs and does not mention any AI or ML components or functionalities.
No.
The device facilitates position changes for comfort, positioning, and pressure relief/reduction, which are supportive functions for a user's well-being but do not directly treat a disease or condition.
No
Explanation: The device description and intended use clearly state that the TRx-CG is a "Power Tilt and Recline System" for wheelchairs, designed to assist with comfort, positioning, and pressure relief by changing the user's physical orientation. There is no mention of it being used to diagnose any medical condition, nor does it process any health-related data for diagnostic purposes.
No
The device description explicitly states "TRx-CG Power Tilt and Recline System," which implies a physical system with hardware components for tilting and reclining a wheelchair. The intended use also describes physical actions (tilting and reclining) performed by the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for changing the position of a power wheelchair user for comfort, positioning, and pressure relief. This is a mechanical function related to mobility and physical support.
- Device Description: The device is described as a "Power Tilt and Recline System." This further reinforces its mechanical nature.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing information about a person's health status, diagnosis, or disease.
- Using reagents or other substances to perform tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The TRx-CG system does not fit this description.
N/A
Intended Use / Indications for Use
The TRx-CG is appropriate for use by any individual who drives a Quickie G-424, S-525, or an S-626 power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:
- Comfort As with any individual able-bodied or disabled changes in position are necessary to maintain a state of comfort.
- Positioning -- Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
- Pressure Relief or Reduction Individuals who wish to, from time to time, redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift.
Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed. TRx-CG Tilt and Recline Systems are to be installed ONLY by qualified Dealers.
Product codes
ITI
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tarsys Tilt and Recline System
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2000
Mr. Allan Boyd General Manager Motion Concepts 101 Bartley Drive Toronto, Ontario Canada M4A 1C9
Re: K994241
Trade Name: TRx-CG Power Tilt and Recline System Regulatory Class: II Product Code: ITI Dated: October 29, 1999 Received: December 15, 1999
Dear Mr. Boyd:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 Drug 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 device in the Federal Register. Please note: 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.
1
Page 2 - Mr. Allan Boyd
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device 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) 594-4595. Additionally, for questions on the promotion and advertising of your device, 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,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K9542 Y/
295424/
Device Name: TRx-CG Power Tilt and Recline System
Statement of Indications For Use:
The TRx-CG is appropriate for use by any individual who drives a Quickie G-424, S-525, or an S-626 power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:
-
- Comfort As with any individual able-bodied or disabled changes in position are necessary to maintain a state of comfort.
-
- Positioning -- Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
-
- Pressure Relief or Reduction Individuals who wish to, from time to time, redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift.
Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed. TRx-CG Tilt and Recline Systems are to be installed ONLY by qualified Dealers.
The above indications for use are identical to those of the Tarsys Tilt and Recline System to which we are claiming substantial equivalence.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Milkman
ision of General Restorative Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)