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K Number
K983066
Device Name
FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300
Manufacturer
TEFTEC CORP.
Date Cleared
1998-11-27

(86 days)

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

The TEFTEC Corporation FirstClass™ Power Tilt Seating System has been designed for use by anyone needing pressure relief while in a seated position. The First Class™ Power Tit Seating System could provide pressure relief by postural change for persons having the following condition or injury: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Hyper Reflexia Chronic Pain Burn Trauma Patient Severe Scar Tissue build up Brown Sequard's Syndrome Multiple Scierosis Heterotrophic Ossification Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Cerebral Palsy Paraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) This is not meant to be an all-inclusive list. Anyone needing pressure relief or positional change that is unable to facilitate those movements independently, would be able to accomplish them with this unit. This would usually be decided by clinical evaluation of the client's strength, sensation level, upper extremity strength, mobility needs and seating needs.

Device Description

FirstClass™ Powered Tilt Seat System, Model S300

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is an FDA 510(k) clearance letter for the FirstClass™ Powered Tilt Seat System, Model S300. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information and instructions for the manufacturer.

The letter includes:

  • Device Name: FirstClass™ Power Tilt Seat System Model S300
  • Indications for Use: Designed for use by anyone needing pressure relief while in a seated position, specifically listing various conditions and injuries that might necessitate such a device. These indications are based on clinical evaluation of a client's strength, sensation level, upper extremity strength, mobility needs, and seating needs.

However, there is no mention of:

  1. A table of acceptance criteria or reported device performance.
  2. Sample sizes or data provenance for any test sets.
  3. Number or qualifications of experts used for ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies or effect sizes.
  6. Standalone algorithm performance studies.
  7. Type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is solely an FDA clearance letter based on substantial equivalence, not a detailed technical report or study showing performance metrics against specific acceptance criteria.

§ 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).