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510(k) Data Aggregation
K Number
K021136Device Name
TEKNIQUE-HOVEROUND POWER WHEEL CHAIRManufacturer
Date Cleared
2002-04-19
(10 days)
Product Code
Regulation Number
890.3860Type
SpecialPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The intended use is to provide mobility to persons limited to a seated position.
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) clearance letter from the FDA for a power wheelchair. It does NOT contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or any of the other AI/algorithm-related questions you've asked. The letter simply states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
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