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K Number
K023347
Device Name
VITAL STIM
Manufacturer
CHATTANOOGA GROUP
Date Cleared
2002-12-06

(60 days)

Product Code
IPF
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Chattanooga VitalStim, a powered muscle stimulator. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain the detailed information about acceptance criteria and specific studies that would allow me to populate the requested table and answer the study-related questions.

Therefore, I cannot provide the requested information based on the provided document. The document is primarily a regulatory clearance letter, not a detailed study report or clinical trial summary.

I am unable to populate the table and answer the questions because the necessary information is not present in the provided text.

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).