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K Number
K972851
Device Name
ZIPPY
Manufacturer
PILLAR TECHNOLOGY, INC.
Date Cleared
1998-01-08

(160 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

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

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "ZIPPY". It does not contain information about acceptance criteria, study details, or performance metrics. Therefore, I cannot provide the requested information based on 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).