(99 days)
Not Found
No
The description focuses on mechanical and electrical components for powered repositioning, with no mention of AI or ML for control, analysis, or decision-making.
No
The document states that the manufacturer makes no claims as to the therapeutic effectiveness of the product, only claims related to safe and reliable powered repositioning. While the described functions can contribute to comfort and pressure relief, which have therapeutic benefits, the device's intended use is described as facilitating position changes for comfort and repositioning, not as a primary therapeutic intervention.
No
Explanation: The device is a power positioning system for wheelchairs designed to provide comfort, repositioning, pressure relief, and versatility for users. Its intended use focuses on physical manipulation and improving accessibility, not on diagnosing medical conditions.
No
The device description clearly outlines hardware components such as a power tilt unit, recline module, elevating seat module, actuators, steel parts, aluminum, and electrical components. While it mentions activation via switches or the wheelchair controller, the core device is a physical system, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TRx-CG Power Positioning System is a mechanical and electrical system designed to provide powered repositioning (tilt, recline, and elevation) for individuals using power wheelchairs. Its function is to change the physical position of the user, not to analyze biological samples.
- Intended Use: The intended use clearly describes the benefits of repositioning for comfort, pressure relief, and accessibility. It does not mention any diagnostic purpose or analysis of biological samples.
- Device Description: The description focuses on the mechanical components, electrical system, and how the device physically moves the user. There is no mention of any components or processes related to analyzing biological samples.
Therefore, the TRx-CG Power Positioning System falls under the category of a medical device, specifically a mobility aid or accessory, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TRx-CG is appropriate for use by any individual who drives a 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:
- All positioning benefits associated with the tilt/recline product -
- Comfort As with any individual -- able-bodied or disabled -- changes in position are necessary to maintain a state of comfort.
- Repositioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
- Pressure relief Individuals who wish, from time to time, to 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.
- Positioning/Versatility Individuals are able to reach higher elevations in a seated position, increasing their range of motion and accessibility.
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 Power Positioning Systems are to be installed ONLY by qualified Dealers.
Product codes
ITI
Device Description
The TRX-CG Power Positioning System consists of a power tilt unit with optional power recline module, shear reduction module and power elevating seat module. The TRX-CG tilt system utilizes a center-of-gravity shift linkage, which causes the seat frame to shift progressively forward throughout the range of tilt. This enhances stability since the center of gravity is kept substantially in place while the user is tilting. The tilt system may be one of two similarly designed systems, one adapted for front wheel drive chairs and one adapted for rear wheel drive chairs. The tilt range of the power positioning system is 55°.
The recline function causes the position of the occupant's back to change by changing the position of the backrest with respect to the seat pan. The shear reduction module works in conjunction with recline to reduce the shear movement between the user and the backrest. This is accomplished using a linkage that slides the backrest down on the back posts as the back reclines. The range of recline of the TRX-CG is 168°.
The elevating seat module allows the user to elevate the entire system by up to 7 in. It consists of a 24 V ball drive pedestal actuator with a maximum capacity of 500 Ibs and a maximum stroke of 7 in.
The maximum occupant weight for the TRX-CG system is up to 400 lbs depending on the features of the base and system modules selected. The minimum seat-to-floor height is 18 ½ in. The TRX-CG is assembled using laser-cut steel parts, steel tube, machined aluminum, delrin blocks and mounting hardware.
The power positioning modules may be activated via two options: using TRx switches or through the wheelchair manufacturer's controller. TRx switches consist of either push button switches or toggle switches.
Additional safety features include a drive lock-out which prevents the user from driving the power chair while tilted beyond a pre-set limit of 20° from the vertical or elevated beyond ½ in. Tilt limit is also available. Electrical components are a maximum of 24 volts with a fuse between the batteries and the relay box and current limiter built into the relay box. Stability of the TRX-CG was tested in our facility to ensure that the safety of the power wheelchair was not compromised by the addition of the power positioning system.
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)
Stability of the TRX-CG was tested in our facility to ensure that the safety of the power wheelchair was not compromised by the addition of the power positioning system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Permobil Powered Wheelchair 1280 (K991658)
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/2 description: The image shows the logo for Motion Concepts. The logo consists of the word "Motion" in a bold, slanted font, with the word "Concepts" in a smaller, upright font above and to the right of "Motion". Above the words is a circular design made of small dashes or dots, giving it a textured appearance. The overall design is simple and modern.
510(k) Summary
Motion Concepts Submitter:
- 84 Citation Dr. Address: Concord, ON L4K 3C1 Canada
- (905) 695-0134 Phone:
- Contact: David Ciolfe
- E-mail: dciolfe@motionconcepts.com
- Date Prepared: April 16, 2002
Device Trade Name:
TRx-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt, Recline, and Power Elevating Seat
Common Name:
Power Positioning System
Classification Name:
Powered Wheelchair
Identification of Predicate Device:
Permobil Powered Wheelchair 1280 (K991658)
1
Description of Device:
The TRX-CG Power Positioning System consists of a power tilt unit with optional power recline module, shear reduction module and power elevating seat module. The TRX-CG tilt system utilizes a center-of-gravity shift linkage, which causes the seat frame to shift progressively forward throughout the range of tilt. This enhances stability since the center of gravity is kept substantially in place while the user is tilting. The tilt system may be one of two similarly designed systems, one adapted for front wheel drive chairs and one adapted for rear wheel drive chairs. The tilt range of the power positioning system is 55°.
The recline function causes the position of the occupant's back to change by changing the position of the backrest with respect to the seat pan. The shear reduction module works in conjunction with recline to reduce the shear movement between the user and the backrest. This is accomplished using a linkage that slides the backrest down on the back posts as the back reclines. The range of recline of the TRX-CG is 168°.
The elevating seat module allows the user to elevate the entire system by up to 7 in. It consists of a 24 V ball drive pedestal actuator with a maximum capacity of 500 Ibs and a maximum stroke of 7 in.
The maximum occupant weight for the TRX-CG system is up to 400 lbs depending on the features of the base and system modules selected. The minimum seat-to-floor height is 18 ½ in. The TRX-CG is assembled using laser-cut steel parts, steel tube, machined aluminum, delrin blocks and mounting hardware.
The power positioning modules may be activated via two options: using TRx switches or through the wheelchair manufacturer's controller. TRx switches consist of either push button switches or toggle switches.
Additional safety features include a drive lock-out which prevents the user from driving the power chair while tilted beyond a pre-set limit of 20° from the vertical or elevated beyond ½ in. Tilt limit is also available. Electrical components are a maximum of 24 volts with a fuse between the batteries and the relay box and current limiter built into the relay box. Stability of the TRX-CG was tested in our facility to ensure that the safety of the power wheelchair was not compromised by the addition of the power positioning system.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human figures in the negative space of its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2002
Motion Concepts David Ciolfe Operations Manager 84 Citation Drive Concord, Ontario Canada L4K 3C1
Re: K021264
Trade Name: TRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt, Recline, and Power Elevating Seat Regulation Number: 890.3850 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: June 17, 2002 Received: June 18, 2002
Dear Mr. Coilfe:
We have reviewed your Section 510(k) premarket 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) 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
3
Page 2 - Mr. David Ciolfe
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark M. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: TRx-CG Power Positioning System
Statement of Indications For Use:
The TRx-CG is appropriate for use by any individual who drives a 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:
* All positioning benefits associated with the tilt/recline product -
-
Comfort As with any individual -- able-bodied or disabled -- changes in position are necessary to maintain a state of comfort.
-
Repositioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
-
Pressure relief Individuals who wish, from time to time, to 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.
-
- Positioning/Versatility Individuals are able to reach higher elevations in a seated position, increasing their range of motion and accessibility.
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 Power Positioning Systems are to be installed ONLY by qualified Dealers.
The above indications for use are identical to those of the Permobil Tit/Recline/Elevating Seat 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)
| Prescription Use
(Per 21 CFR 801.109) | Awer-The-Counter Use
OK
(Optional Format 1-2-96) |
|------------------------------------------|--------------------------------------------------------|
| | Division Sion-Off) |
| | Division of General, Restorative |
| | and Neurological Devices |
| 5 | ANA
510(k) Number. |
| | |