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K Number
K061116
Device Name
MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR
Manufacturer
MOBILIFE, LLC
Date Cleared
2006-07-03

(73 days)

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

The mobilitie Model ( Mobil Raizer 22) Power Wheelchair The mobile to inback or powered personal mobility clectric wheel chair with a sent cupable to be raised 22 inch designed for an adult occupant that wrighs up to 215 pounds (depending on seating option). The device provides maximum transport mobility and advantage of a seat electrically for a Person able to Can be raised that joy - Stick Controller. sperate the standard

Device Description

Powered wheelchair

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a power wheelchair, Mobilife Model (Mobil Raizer 22). This document focuses on the regulatory clearance process for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

Therefore, I cannot answer your request based on the provided text. The questions you've asked (about sample sizes, ground truth, expert qualifications, MRMC studies, etc.) are relevant to the evaluation of AI/ML software as a medical device, which is not what this document describes.

§ 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).