Cleared Special

SOZO Pro

K230530 · ImpediMed Limited · Gastroenterology & Urology

May 2023

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K230530 is an FDA 510(k) clearance for the SOZO Pro, 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 May 4, 2023, 66 days after receiving the submission on February 27, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number	K230530 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2023
Decision Date	May 04, 2023
Days to Decision	66 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

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)