Search Results
Found 1 results
510(k) Data Aggregation
(85 days)
HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
The intended use of the HP-3 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control.
Model HP-3, Power Wheelchair
The provided document is a 510(k) clearance letter from the FDA for a power wheelchair (Model HP-3). This document does not contain the information requested for acceptance criteria and study details for a medical device's performance.
The letter simply states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory compliance and general controls, but not specific performance criteria or a study demonstrating achievement of those criteria.
Therefore, I cannot extract the requested information from this document.
Ask a specific question about this device
Page 1 of 1