OBH — Monitor, Extracellular Fluid, Lymphedema, Extremity Class II
FDA product code OBH covers "Monitor, Extracellular Fluid, Lymphedema, Extremity", a Class II medical device regulated under 21 CFR 870.2770. Submissions are reviewed by the Cardiovascular panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OBH
- Device Class
- Class II
- Regulation Number
- 870.2770
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253224 | impedimed limited | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | January 28, 2026 |
| K230530 | impedimed limited | SOZO Pro | May 4, 2023 |
| K220557 | delfin technologies | MoistureMeterD Compact, LymphScanner | May 27, 2022 |
| K180126 | impedimed limited | SOZO | April 16, 2018 |
| K172122 | impedimed limited | SOZO | August 11, 2017 |
| K143310 | delfin technologies | MoisturemeterD | November 19, 2015 |
| K130338 | impedimed limited | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS | May 31, 2013 |
| K100811 | impedimed limited | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 | November 4, 2011 |
| K080825 | impedimed pty | IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 | October 3, 2008 |
| K050415 | impedimed pty | IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS | March 30, 2007 |