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510(k) Data Aggregation
K Number
K024325Device Name
JI-EE ELECTRIC SCOOTER, ESTHETE ES 1Manufacturer
Date Cleared
2003-04-04
(99 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
JI-EE Electric Scooter, Esthete ES 1
AI/ML Overview
This document is a marketing clearance letter from the FDA for a medical device (JI-EE Electric Scooter, Esthete ES 1). It does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Therefore, I cannot provide the requested information based on the given input, as it is not present in the document.
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