Data / Medical devices / Australia / Impedimed Limited
Impedimed Limited: FDA-registered device maker in Lindfield New South Wales, Australia, 12 510(k) clearances
Impedimed Limited is registered with the FDA (registration 3004782476) in Lindfield New South Wales, Australia. It lists 4 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 17, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004782476
- Address
- Suite 31C, 12-18 Tryon Rd., Lindfield New South Wales, Australia, 2070
- Owner or operator
- Impedimed Limited (10023581)
- Roles
- Manufacturer
- First device listed
- December 4, 2007
- Registered through
- 2026
- Brand names listed
- BODY COMP ANALYZER, IMP SFB7, Bis Extra Cellular Fluid Analysis, Body Composition Analysis, Extracellular Fluid Analysis, IMED-Z FLUID STATUS MONITOR, L-Dex U400, SOZO, SOZO Pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adjunct Monitor, Protein Calorie Malnutrition | QJB | 2 | Manufacturer | accessdata.fda.gov |
| Analyzer, Body Composition | MNW | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Extracellular Fluid, Lymphedema, Extremity | OBH | 2 | Manufacturer | accessdata.fda.gov |
| Plethysmograph, Impedance | DSB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 17, 2023 | K232089 | SOZO Pro | DSB | Substantially Equivalent | ImpediMed Limited | accessdata.fda.gov |
| May 4, 2023 | K230531 | SOZO Pro | QJB | Substantially Equivalent | ImpediMed Limited | accessdata.fda.gov |
| May 4, 2023 | K230530 | SOZO Pro | OBH | Substantially Equivalent | ImpediMed Limited | accessdata.fda.gov |
| December 22, 2017 | K172507 | SOZO | DSB | Substantially Equivalent | ImpediMed Limited | accessdata.fda.gov |
| August 11, 2017 | K172122 | SOZO | OBH | Substantially Equivalent | ImpediMed Limited | accessdata.fda.gov |
| June 5, 2015 | K142503 | IMED-Z FLUID STATUS MONITOR | DSB | Substantially Equivalent | Intersection Medical, Inc. | accessdata.fda.gov |
| May 31, 2013 | K130338 | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS | OBH | Substantially Equivalent | ImpediMed Limited | accessdata.fda.gov |
| November 4, 2011 | K100811 | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 | OBH | Substantially Equivalent | ImpediMed Limited | accessdata.fda.gov |
| October 3, 2008 | K080825 | IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 | OBH | Unknown | Impedimed Pty , Ltd. | accessdata.fda.gov |
| March 30, 2007 | K050415 | IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS | OBH | Unknown | Impedimed Pty , Ltd. | accessdata.fda.gov |
| April 4, 2006 | K052319 | IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 | MNW | Substantially Equivalent | Impedimed Pty , Ltd. | accessdata.fda.gov |
| July 13, 2005 | K050395 | IMPEDIMED - BODY COMPOSITION ANALYSIS | MNW | Substantially Equivalent | Impedimed Pty , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 17, 2023 | 92943 | Class II | Ongoing | SOZO Bilateral Arm L-Dex Software | Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and more aggressive intervention. | accessdata.fda.gov |
Compare with other makers
- All makers of Plethysmograph, Impedance
- All makers of Monitor, Extracellular Fluid, Lymphedema, Extremity
- All makers of Adjunct Monitor, Protein Calorie Malnutrition
- All makers of Analyzer, Body Composition
Updated October 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.