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510(k) Data Aggregation
K Number
K011744Manufacturer
Date Cleared
2001-08-24
(80 days)
Product Code
Regulation Number
890.3860Type
AbbreviatedPanel
Physical MedicineReference & Predicate Devices
N/A
Why did this record match?
Device Name :
HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The intended use of the HP-5 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control and also allow this chair to fold for easy transportation.
Device Description
Model HP-5, Power Wheelchair
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for a power wheelchair, not a study describing acceptance criteria and device performance. Therefore, I cannot extract the requested information. The letter confirms substantial equivalence to a predicate device but does not detail studies or acceptance criteria for the Model HP-5.
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