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510(k) Data Aggregation
K Number
K032643Device Name
JUSTWIN SCOOTER, JS-3013Manufacturer
Date Cleared
2003-12-02
(97 days)
Product Code
Regulation Number
890.3800Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Device Description
JUSTWIN SCOOTER, JS-3013
AI/ML Overview
The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "JUSTWIN SCOOTER, JS-3013". This document is a regulatory approval notice and does not contain information about acceptance criteria, device performance, study data, or clinical trials that would address the questions posed.
Therefore, I cannot provide the requested information based on the given text.
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