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K Number
K990139
Device Name
KENSTONE
Manufacturer
KENDA USA
Date Cleared
1999-04-29

(100 days)

Product Code
IOR
Regulation Number
890.3850
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

THIS DEVICE IS A CHAIR WITH LARGE WHEELS WHICH ARE USED TO MOVE AND TURN THE CHAIR BY THE USER. IT CAN BE USED ON A FLAT SURFACE IN A ROOM, A YARD, OR PAVED SURFACE. IT IS ESPECIALLY USEFUL TO THOSE WHO ARE UNABLE TO WALK OR LACK USE OF THEIR LEGS, ALLOWING THE USER A DEGREE OF MOBILITY. THIS CHAIR DOES NOT HAVE A RECLINING FEATURE.

Device Description

Mechanical (manual) wheelchair #KE-1M

AI/ML Overview

The provided text describes a Premarket Notification 510(k) Summary for a "Mechanical (manual) wheelchair #KE-1M" by KENSTONE METAL CO., LTD. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for a complex medical device with an AI component. Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.

The document primarily provides administrative and regulatory details:

  • Applicant: KENSTONE METAL CO., LTD.
  • Device Name: Mechanical (manual) wheelchair #KE-1M
  • Trade Name: Kenstone
  • Classification: Class 1
  • Equivalent Device: Graham Field Vista Model 31-52005510
  • Intended Use: To aid mobility of persons having difficulty walking
  • Technological characteristics: Function and design is same as equivalent device
  • K Number: K990139
  • FDA Decision Date: April 29, 1999

The FDA's letter states that the device is "substantially equivalent" to legally marketed devices, allowing it to proceed to market under general controls. This type of 510(k) submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as a predicate device, often without requiring extensive clinical trials with pre-defined acceptance criteria and statistical performance measures as would be expected for novel or high-risk devices, especially those incorporating AI.

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).