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K Number
K042033
Device Name
HOVEROUND POWER WHEELCHAIR, MODEL HD700
Manufacturer
HOVEROUND CORP.
Date Cleared
2004-09-29

(62 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

Not Found

AI/ML Overview

This document does not contain the information requested for acceptance criteria and the study details.

The provided text is a 510(k) clearance letter from the FDA for a powered wheelchair (Hoveround Power Wheelchair, model HD700). It states that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed.

However, this letter does not include:

  1. A table of acceptance criteria or reported device performance.
  2. Details about a specific study, including sample sizes, data provenance, ground truth establishment, or expert qualifications.
  3. Information on MRMC studies or standalone algorithm performance, as it's a physical medical device, not an AI/software device.

The letter primarily focuses on the regulatory clearance for the device based on substantial equivalence, not on the detailed results of a performance study against specific acceptance criteria.

§ 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).