Impedimed Pty, Ltd.
AustraliaFDA applicant, unverified
- Devices
- 4
What Impedimed Pty, Ltd. makes
Impedimed manufactures bioelectrical impedance analysis devices, including systems for measuring body composition and extracellular fluid levels. These include handheld and bench-top models designed to assess parameters such as fat mass, muscle mass, and hydration status. The devices use impedance spectroscopy to provide quantitative health metrics for clinical and research applications.
The company’s portfolio is regulated as Class II medical devices in the US, with products authorised via the 510(k) pathway. These devices are listed under the FDA’s regulatory framework. The company is based in the United States.
Catalogue
Impedimed-Extracellular Fluid Analysis Ref K050415
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Impedimed - Body Composition Analysis Ref K050395
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Impedimed Pty, Ltd. have in the registry?
The registry currently lists 4 devices for Impedimed Pty, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Impedimed Pty, Ltd.'s devices?
Among its 4 most recently registered devices, Impedimed Pty, Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Impedimed Pty, Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Impedimed Pty, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Impedimed Pty, Ltd. in the registry?
The most recently registered devices listed for Impedimed Pty, Ltd. include IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS, IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7, IMPEDIMED - BODY COMPOSITION ANALYSIS and IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400.