Monitor, Extracellular Fluid, Lymphedema, Extremity
OBH is the FDA product code for Monitor, Extracellular Fluid, Lymphedema, Extremity, a class II device type, regulated under 21 CFR 870.2770. FDA's definition for this code reads: "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)". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- OBH
- Device name
- Monitor, Extracellular Fluid, Lymphedema, Extremity
- FDA 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)
- Regulation
- 21 CFR 870.2770
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 10
- Ingested recalls
- 1
Clearances, product code OBH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code OBH| Applicant | Clearances |
|---|---|
| Impedimed, Inc. | 8 |
| Delfin Technologies Ltd | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
