SOZO Body Fluid Analyzer

Basic Information

• Brand Name: SOZO Body Fluid Analyzer
• Primary DI: B27728269950
• Version / Model: 2826995
• Catalog Number: 2826995
• Company Name: IMPEDIMED LIMITED
• Labeler DUNS: 757258843
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-16
• Public Version: 1
• Public Version Date: 2022-05-24
• Public Version Status: New
• Public Device Record Key: 6f1b62e1-91ae-4c92-bea5-4c6d61a818cf

Device Description

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor. (Repackaged for use in Clinical evaluations (Trials))

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	Cardiovascular	870.2770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36022	Bioelectrical body composition analyser	An electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B27728269951	HIBCC	Box	1	In Commercial Distribution
Primary	B27728269950	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K172122	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius