IMPEDIMED LIMITED

Address:Unit 1, 50 Parker Court,Brisbane Queensland,AU

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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

Monitor, Extracellular Fluid, Lymphedema, Extremity (OBH) (1)

Premarket Exempt

No Yes

Clear

SOZOThrive - B277SOZOTHRIVE0 Catalog Number : SOZOthrive

Device Description : Application- impedance analysis software utilizing impedance ratios that are dis Application- impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluidvolume differences between the limbs and is presented to the clinician on an L-Dex scale.

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : OBH

Prescription Use : Yes

Device Count : 1

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