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510(k) Data Aggregation
K Number
K120922Device Name
GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
Manufacturer
Date Cleared
2013-02-07
(317 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
SELECTIVEMED COMPONENTS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction
Device Description
Guardian Dysphagia dual channel NMES is a lightweight battery powered dual channel neuromuscular stimulation device used for treating patients suffering from dysphagia. It is a prescription device administered to patients by or under the direction of a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics. The intended patient outcome is to regain control of muscles used to swallow food and drink liquids without aspirating. It is to be used with Guardian 150 electrode or other compatible electrodes cleared for the same indications for use, as well as lead wires.
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