LogoFDA 510(k) Search
K Number
K022617
Device Name
COMFY HIGH RISER WHEELCHAIR
Manufacturer
LENJOY MEDICAL ENGINEERING, INC.
Date Cleared
2002-09-13

(37 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

INTENDED USE OF THE COMFY Hibt THE WHEEL CHAIR MODEL I is desiGNED THE USER A CHANGE IN SITTING A SCENDED THE Fully EXTENDED ELEVATION.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for a manual wheelchair. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML-driven device.

Therefore, I cannot populate the requested table and answer the following questions:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method for the test set
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

The document focuses on the administrative aspects of FDA clearance for a mechanical device (a manual wheelchair), including its identity, classification, and substantial equivalence to legally marketed predicate devices. It does not involve any AI/ML components or performance metrics typically associated with such technologies.

§ 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).