(29 days)
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.
TRx-CG Power Tilt and Recline System
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a power tilt and recline system for wheelchairs, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and indications for use, but no specific performance metrics or study details are provided.
§ 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).