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K Number
K983808
Device Name
ZIPPY
Manufacturer
PILLAR TECHNOLOGY, INC.
Date Cleared
1999-10-14

(351 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

To provide an optional means of mobility for physically challenged people.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to Pillar Technology, Inc. for their "Zippy Powered Wheel Base, Model TE 888W". It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. It is a regulatory approval letter, not a study report or clinical trial summary.

Therefore, I cannot provide the requested information based on this document.

§ 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).