K180126 is an FDA 510(k) clearance for the SOZO. This device is classified as a Monitor, Extracellular Fluid, Lymphedema, Extremity (Class II - Special Controls, product code OBH).
Submitted by ImpediMed Limited (Pinkenba, AU). The FDA issued a Cleared decision on April 16, 2018, 90 days after receiving the submission on January 16, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770. 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).
| 510(k) Number | K180126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2018 |
| Decision Date | April 16, 2018 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OBH - Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |
| 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) |