FDA.reportPublic FDA data

IMPEDIMED, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30056999423005699942IMPEDIMED, INC.1Y2026-01-015900 Pasteur Ct Ste 125 Carlsbad CA US 92008

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B277249SFB70Imp SFB7 - BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor.ROW Refurbished-Device+61738603700xx@xx.xx
B27725269950SOZO Body Fluid Analyzer - SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor. Demo Device+61738603700enquiries@impedimed.com
B27727270000SOZO Body Fluid Analyzer - SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor.+61738603700enquiries@impedimed.com
B277292DTE1Dual Tab Electrode - Lymphederma Dual Tab Electrodes; each pouch contains 60 single use gel backed electrodes+61738603700XX@XX.com
B277292DTE1Dual Tab Electrode - Lymphederma Dual Tab Electrodes; each pouch contains 60 single use gel backed electrodes760-585-2100XX@XX.com
B277293SFB7CD0BioImp Body Composition Analysis Software SFB7 - Bio Impedence analysis software US877-247-0111XX@xx.xx
B277293SFB7CD0BioImp Body Composition Analysis Software SFB7 - Bio Impedence analysis software US760-585-2100XX@xx.xx
B277299MSTE1Metagenics Single Tab Electrode - Single Tab Electrode, each pouch contains 100 single use gel backed electrodes.+61738603700XX@XX.XXX
B277299MSTE1Metagenics Single Tab Electrode - Single Tab Electrode, each pouch contains 100 single use gel backed electrodes.760 585 2100XX@XX.XXX
B277SOZOPRO0SOZOpro - Application- Bio-Impendence Analysis software used for determining Body Composition+61738603700enquiries@impedimed.com
B277SOZOTHRIVE0SOZOThrive - 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.+61738603700enquiries@impedimed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
665891395870155K232089SOZO ProDSB2023-10-17
665891764356201K230531SOZO ProQJB2023-05-04
665891613913790K230530SOZO ProOBH2023-05-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSB12023-10-17
OBH12023-05-04
QJB12023-05-04

PMN#

SOZO

2021-04-19

ImpediMed Limited

SOZO

2019-11-25

ImpediMed Limited

SOZO

2018-04-16

ImpediMed Limited

SOZO

2017-12-22

ImpediMed Limited

SOZO

2017-08-11

ImpediMed Limited

GUDID#

SOZOapplication - 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.

IMPEDIMED LIMITED

2019-08-01

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