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K Number
K981837
Device Name
TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS
Manufacturer
MOTION CONCEPTS
Date Cleared
1998-07-09

(44 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Statement of Indications For Use: Otatement of manoutiente 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:

  • 6. Comfort -- As with any individual -- able-bodied -- changes in position are necessary to maintain a state of comfort.
    1. Positioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
    1. 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.

The above indications for use are identical to those of the Tarsys Tilt and Recline System to which we are claiming substantial equivalence.

Device Description

TRx-CG Power Tilt and Recline System

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called the "TRx-CG Center-of-Gravity Shifting Power Tilt and Recline Systems." It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about:

  • Acceptance criteria
  • Study that proves the device meets acceptance criteria
  • Device performance
  • Sample sizes (test or training sets)
  • Data provenance
  • Number of experts or their qualifications for ground truth establishment
  • Adjudication method
  • MRMC comparative effectiveness study
  • Standalone algorithm performance
  • Type of ground truth used
  • How ground truth for training set was established

The document is a regulatory clearance and not a performance study report. Therefore, I cannot extract the requested information from the provided text.

§ 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).