LogoFDA 510(k) Search
K Number
K022993
Device Name
HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS
Manufacturer
HOVEROUND CORP.
Date Cleared
2002-12-02

(84 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Hoveround Rehab Seating System is intended for people using a powered wheelchair and requiring positional change.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information regarding acceptance criteria or a study that proves a device meets such criteria.

The document is a US FDA 510(k) clearance letter for the "Hoveround Rehab Seating System." This letter:

  • Confirms that the device is substantially equivalent to a legally marketed predicate device.
  • States the regulatory class and product code.
  • Outlines general control provisions the manufacturer must adhere to (registration, listing, GMP, labeling, etc.).
  • Provides contact information for regulatory compliance.
  • Includes the Indications For Use.

It does not contain details about:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets or data provenance.
  • Number/qualifications of experts for ground truth.
  • Adjudication methods.
  • MRMC comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Sample size for training sets.
  • How ground truth for training sets was established.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided input.

§ 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).