MED SYSTEMS INC

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Percussor, Powered-Electric (BYI) (1)

Premarket Exempt

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Electro Flo® Percussor - 00862528000302 Catalog Number :

Device Description : The Electro Flo 5000 is an electrically powered percussor, intended to assist in The Electro Flo 5000 is an electrically powered percussor, intended to assist in airway clearance therapy when the physician’s choice of therapy is external manipulation of the thorax. Additionally, the Electro Flo 5000 is indicated for external manipulation of the thorax to promote airway clearance and improve bronchial drainage.

Device Class : 2

Duns Number: 039978200

Premarket Exempt : No

Product Code : BYI

Prescription Use : Yes

Device Count : 1

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