Data / Medical devices / United States / Impedimed, Inc.
Impedimed, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 3 510(k) clearances
Impedimed, Inc. is registered with the FDA (registration 3005699942) in Carlsbad, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005699942
- Address
- 5900 Pasteur Ct Ste 125, Carlsbad, CA, United States, 92008
- Owner or operator
- Impedimed, Inc. (9085941)
- Roles
- Specification developer
- First device listed
- October 27, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adjunct Monitor, Protein Calorie Malnutrition | QJB | 2 | Specification developer | accessdata.fda.gov |
| Analyzer, Body Composition | MNW | 2 | Specification developer | accessdata.fda.gov |
| Monitor, Extracellular Fluid, Lymphedema, Extremity | OBH | 2 | Specification developer | accessdata.fda.gov |
| Plethysmograph, Impedance | DSB | 2 | Specification developer | 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 |
Compare with other makers
- All makers of Monitor, Extracellular Fluid, Lymphedema, Extremity
- All makers of Adjunct Monitor, Protein Calorie Malnutrition
- All makers of Analyzer, Body Composition
- All makers of Plethysmograph, Impedance
Updated October 17, 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.