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K Number
K240270
Device Name
Electric wheelchair (S7018)
Manufacturer
Guangdong Prestige Technology Company Limited
Date Cleared
2024-08-27

(209 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 Electric wheelchair is a motor driven transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated position.

Device Description

Electric wheelchair (S7018)

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Electric wheelchair (S7018)" does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets them.

The document is a standard FDA clearance letter, which primarily states that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory requirements. It does not include information about:

  • Specific acceptance criteria in a tabled format.
  • The results of any performance studies against those criteria.
  • Sample sizes for test sets or data provenance.
  • Details about expert involvement in establishing ground truth.
  • Adjudication methods.
  • MRMC studies or effect sizes.
  • Standalone algorithm performance.
  • Types of ground truth used.
  • Training set details (size or ground truth establishment).

The letter indicates that the device is an "Electric wheelchair" for "mobility to a disabled or elderly limited to a seated position." For such a device, performance criteria typically relate to safety, durability, speed, battery life, weight capacity, maneuverability, and electromagnetic compatibility, often tested against established industry standards (e.g., ISO, ANSI/RESNA). However, these specific test results and acceptance criteria are not detailed in this FDA clearance letter. They would typically be found in the full 510(k) submission, which is not publicly available in this format.

Therefore, I cannot populate the table or provide the requested details based on the provided 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).