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K Number
K012846
Device Name
ZIPPY, MODEL I88WA
Manufacturer
PILLAR TECHNOLOGY, INC.
Date Cleared
2001-11-20

(89 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 for the "Zippy" powered wheelchair. It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance as it would be presented for an AI/ML-based medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document. The document primarily focuses on:

  • Regulatory Clearance: Affirming that the device meets the substantial equivalence requirements for market entry.
  • Device Classification: Assigning a regulatory class (Class II) and product code (ITI).
  • General Controls: Reminding the manufacturer of ongoing regulatory responsibilities.
  • Indications for Use: Stating the intended purpose of the device (to provide an optional means of mobility for physically challenged people).

§ 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).