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510(k) Data Aggregation
K Number
K981121Device Name
AMIGO RTManufacturer
Date Cleared
1998-06-30
(95 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
Intended use is personal transportation for senior active and walking impaired individuals.
Device Description
Not Found
AI/ML Overview
The provided documents are a 510(k) clearance letter from the FDA for a device named "Amigo RT." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, the letters do not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications for the device.
Therefore, I cannot provide the requested information based on the given input. The documents are purely administrative regarding regulatory clearance.
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