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K Number
K063475
Device Name
IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)
Manufacturer
IMC-HEARTWAY, LLC
Date Cleared
2007-01-23

(68 days)

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

The intended use of the Model-Tiara (P4AS) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding a powered wheelchair (IMC-Heartway, LLC Model-Tiara (P4AS)). It confirms substantial equivalence to a predicate device and allows the device to be marketed.

The document does not contain any information about acceptance criteria, studies, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or adjudication methods for an AI/ML powered medical device. The information requested pertains to the evaluation of AI/ML performance, which is not applicable to this 510(k) clearance for a powered wheelchair.

§ 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).