K253224 is an FDA 510(k) clearance for the MySOZO Software version 6.0.1.2 (SW version 6.0.1.2), 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 January 28, 2026, 121 days after receiving the submission on September 29, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K253224 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2025 |
| Decision Date | January 28, 2026 |
| Days to Decision | 121 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) |