Impedimed, Inc.
Lindfield New South Wales, AU
IMPEDIMED, INC. appears in FDA device records in Lindfield New South Wales, AU. FDA records list 16 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Impedimed, Inc. between 2005 and 2026. The busiest year on record is 2023, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | OBH | Substantially Equivalent | |
| K232089 | SOZO Pro | DSB | Substantially Equivalent | |
| K230531 | SOZO Pro | QJB | Substantially Equivalent | |
| K230530 | SOZO Pro | OBH | Substantially Equivalent | |
| K203473 | SOZO | DSB | Substantially Equivalent | |
| K193410 | SOZO Body Fluid Analyzer | DSB | Substantially Equivalent | |
| K190529 | SOZO | QJB | Substantially Equivalent | |
| K180126 | SOZO | OBH | Substantially Equivalent | |
| K172507 | SOZO | DSB | Substantially Equivalent | |
| K172122 | SOZO | OBH | Substantially Equivalent | |
| K130338 | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS | OBH | Substantially Equivalent | |
| K100811 | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 | OBH | Substantially Equivalent | |
| K080825 | IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 | OBH | Unknown | |
| K050415 | IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS | OBH | Unknown | |
| K052319 | IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 | MNW | Substantially Equivalent | |
| K050395 | IMPEDIMED - BODY COMPOSITION ANALYSIS | MNW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005699942 | 3005699942 | IMPEDIMED, INC. | 5900 Pasteur Ct Ste 125, Carlsbad, CA 92008 US | 2026 | |
| 3004782476 | 3004782476 | Impedimed Limited | Suite 31C, 12-18 Tryon Rd., Lindfield New South Wales 2070 AU | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0155-2024 | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain