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K Number
K190699
Device Name
Rowheels Revolution 1.0
Manufacturer
Rowheels Inc.
Date Cleared
2019-05-09

(52 days)

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

The Rowheels Revolution 1.0 Wheelchair is to provide mobility to persons limited to a sitting position.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a mechanical wheelchair called "Rowheels Revolution 1.0". This document confirms the device's substantial equivalence to a predicate device but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth methodologies for an AI/ML powered device.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

§ 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).