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K Number
K100084
Device Name
MULTI FRAME WHEELCHAIR
Manufacturer
R82 A/S
Date Cleared
2010-04-12

(90 days)

Product Code
IOR
Regulation Number
890.3850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Multi Frame's intended function and use is provide mobility to children limited to a sitting position.

Device Description

The Wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front privoting casters for steering and turning.

AI/ML Overview

I am sorry, but the provided document is a letter from the FDA regarding a 510(k) premarket notification for a Multi Frame Wheelchair. It does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence or machine learning model validation. Therefore, I cannot extract the requested information.

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).