Data / Medical devices / United States / Mendtronix, Inc.
Mendtronix, Inc.: FDA-registered device maker in San Diego, CA, United States, 2 510(k) clearances
Mendtronix, Inc. is registered with the FDA (registration 3010844918) in San Diego, CA, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 13, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010844918
- Address
- 1855 Dornoch Court Suite 100, San Diego, CA, United States, 92154
- Owner or operator
- Mendtronix Inc. (10053335)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- June 8, 2022
- Registered through
- 2026
- Brand names listed
- BioImp Body Composition Analyzer; SOZO system; SOZOapp with SOZOpro measurement module; SOZOhub database, Burble, Carecube Negative Pressure Isolation Chamber, HeartBeam AIMIGo System; HeartBeam System, Multiphze Enclosed Bladder Irrigation System - includes urinary drainage bag and drape
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition | MNW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Chamber, Patient Isolation | LGM | 2 | Contract manufacturer | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Contract manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| December 13, 2024 | K231424 | HeartBeam AIMIGo(TM) System | MWJ | Substantially Equivalent | Heartbeam, Inc. | accessdata.fda.gov |
| April 4, 2006 | K052319 | IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 | MNW | Substantially Equivalent | Impedimed Pty , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Irrigator, Sinus
- All makers of Analyzer, Body Composition
- All makers of Chamber, Patient Isolation
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
- All makers of Collector, Urine, (And Accessories) For Indwelling Catheter
Updated December 13, 2024. 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.