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K Number
K042920
Device Name
HOVEROUND SE-3 POWERCHAIR
Manufacturer
HOVEROUND CORP.
Date Cleared
2004-12-03

(42 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
PM
Reference & Predicate Devices
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

Hoveround SE-3 Powerchair

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a powered wheelchair, the "Hoveround SE-3 Powerchair." This document does not describe acceptance criteria for a device, a study that proves the device meets acceptance criteria, or any of the specific details requested regarding sample sizes, ground truth establishment, or expert involvement.

Instead, this document is an administrative notification that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements and provides contact information for further guidance.

Therefore, I cannot provide the requested information based on the input text.

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).