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

Analyzer, Body Composition (MNW) (4) Electrode, Electrocardiograph (DRX) (4) Monitor, Extracellular Fluid, Lymphedema, Extremity (OBH) (2) Plethysmograph, Impedance (DSB) (1)

Premarket Exempt

No Yes

Clear

Body Composition Dual Tab Electrode - B277292BCE1 Catalog Number : 292-BCE

Device Description : Body Composition Dual Tab Electrode, each pouch contains 60 single use gel backe Body Composition Dual Tab Electrode, each pouch contains 60 single use gel backed electrodes.

Device Class :

Duns Number: 757258843

Premarket Exempt : No

Product Code : DRX

Prescription Use : No

Device Count : 60

Body Composition Analysis Software - B277292DF50CD0 Catalog Number : 292-DF50CD

Device Description : DF50 Body Composition Analysis Software

Device Class :

Duns Number: 757258843

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Dual Tab Electrode - B277292DTE1 Catalog Number : 292-DTE

Device Description : Lymphederma Dual Tab Electrodes; each pouch contains 60 single use gel backed electrodes

Device Class :

Duns Number: 757258843

Premarket Exempt : No

Product Code : DRX

Prescription Use : No

Device Count : 60

Single Tab Electrode - B277292STE1 Catalog Number : 292-STE

Device Description : Single Tab Electrode, each pouch contains 100 single use gel backed electrodes.

Device Class :

Duns Number: 757258843

Premarket Exempt : No

Product Code : DRX

Prescription Use : No

Device Count : 100

U400 ImpSoft Software - B277292U400CD0 Catalog Number : 292-U400CD

Device Description : Impsoft data management & analysis software

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : OBH

Prescription Use : Yes

Device Count : 1

BioImp Body Composition Analysis Software SFB7 - B277293SFB7CD0 Catalog Number : 293-SFB7CD

Device Description : Bio Impedence analysis software US

Device Class :

Duns Number: 757258843

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Metagenics Single Tab Electrode - B277299MSTE1 Catalog Number : 292-MSTE

Device Description : Single Tab Electrode, each pouch contains 100 single use gel backed electrodes.

Device Class :

Duns Number: 757258843

Premarket Exempt : No

Product Code : DRX

Prescription Use : No

Device Count : 100

BioImp Body Composition Analysis Software SFB7 - B277299SFB7CD0 Catalog Number : 299-SFB7CD

Device Description : Bio Impedance analysis software ROW

Device Class : 2

Duns Number: 757258843

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

SOZOapplication - B277SOZOAPP0 Catalog Number :

Device Description : Multipurpose software application- impedance analysis software that supports the Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume 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 : DSB, OBH

Prescription Use : Yes

Device Count : 1

SOZOpro - B277SOZOPRO0 Catalog Number : SOZOpro

Device Description : Application- Bio-Impendence Analysis software used for determining Body Composition

Device Class : 2

Duns Number: 757258843

Premarket Exempt : Yes

Product Code : MNW

Prescription Use : No

Device Count : 1

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