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510(k) Data Aggregation
K Number
K190699Device Name
Rowheels Revolution 1.0Manufacturer
Date Cleared
2019-05-09
(52 days)
Product Code
Regulation Number
890.3850Type
TraditionalPanel
Physical MedicineReference & 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.
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