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K Number
K101611
Device Name
RELAY POWER WHEELCHAIR
Manufacturer
DALTON INSTRUMENT CORP.
Date Cleared
2010-09-29

(113 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 intended use of the Relay is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) summary for the Relay powered wheelchair (K101611) and does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The 510(k) letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices. It lists the device name "Relay" and its regulation number and name. However, it does not include details on specific performance metrics, clinical studies, or acceptance criteria typical for product performance evaluations.

Therefore, I cannot provide the requested information 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).