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K Number
K011846
Device Name
BIOTECH POWERED WHEELCHAIR, C650PW
Manufacturer
ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
Date Cleared
2002-01-18

(220 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 device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a "Biotech Powered Wheelchair C650PW". This document pertains to the regulatory approval of a physical medical device (a powered wheelchair), not a software or AI-based medical device.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies is not applicable to this document. The concepts of "device performance" in this context refer to the physical functionality, safety, and effectiveness of the wheelchair, which would be evaluated through different types of testing (e.g., mechanical, electrical, clinical trials for mobility) rather than AI model performance metrics like sensitivity, specificity, or AUC.

§ 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).