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K Number
K994107
Device Name
AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.
Manufacturer
AMYLIOR, INC.
Date Cleared
2000-01-13

(38 days)

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

The intended use of the device is to provide posterior tilting for positioning and pressure relief in a powered wheelchair.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a power tilt system for wheelchairs. It confirms the device's substantial equivalence to a predicate device and its classification.

The document does not contain any information about:

  • Acceptance criteria or reported device performance for a study.
  • Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone studies, or ground truth details for any testing.
  • Training set information.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.

§ 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).