We use cookies to make your visit to our website as pleasant as possible. If you continue to use the website, you agree to our privacy policy and to the use of cookies. More information about cookies and how ImpediMed uses them is available
here
.
Accept Cookies
NAPBC STANDARDS
Meet Accreditation Standards with a Lymphedema Prevention Program
Learn More
X
Products
SOZO® Digital Health Platform
SOZO
®
Applications
L-Dex
®
Analysis for Lymphedema
BodyComp™ Analysis
Segmental BodyComp
™
Analysis
HF-Dex™ Analysis for Heart Failure
Request SOZO
®
Demo
Research Devices
SFB7
ImpediVET
Technology
What is BIS?
Specialty
Lymphedema Prevention Program
Heart Failure
Patients
Find an L-Dex
®
Provider
Preventing Lymphedema
Lymphedema Community Resources
Resources & Support
Resources
NAPBC Standards
NCCN Guidelines
®
The PREVENT Trial
Clinical Evidence
What is BIS?
Privacy & Security
Webinars & Events
Knowledge Center
Videos
Device Set-up & Use
Software User Guides
L-Dex
®
Analysis for Lymphedema
BodyComp™ Analysis
Segmental BodyComp
™
Analysis
HF-Dex™ Analysis for Heart Failure
Lymphedema Prevention Program
Support
Frequently Asked Questions
IFU Documents
Quality & Regulatory Certificates
Discontinued Products
Register Your Product
Request Support
About
Careers
Investor Relations
Leadership
Newsroom
Patents
Request Quote
Find Provider
Investors
MySOZO
Contact
Find Provider
Investors
MySOZO
Contact
Search for:
Products
Products
SOZO® Digital Health Platform
SOZO
®
Applications
L-Dex
®
Analysis for Lymphedema
BodyComp
™
Analysis
Segmental BodyComp
™
Analysis
HF-Dex™ Analysis for Heart Failure
Research Devices
SFB7
ImpediVET
Technology
What is BIS?
Lymphedema Prevention Program
Specialty
Breast Cancer
Heart Failure
Rehabilitation & Therapy
Research
Request SOZO
®
Demo
Patients
Find Provider
Preventing Lymphedema
Lymphedema Community Resources
Resources & Support
Resources
NAPBC Standards
NCCN Guidelines®
The PREVENT Trial
Clinical Evidence
What is BIS?
Privacy & Security
Webinars & Events
Knowledge Center
Videos
Device Set-up & Use
Software User Guides
L-Dex
®
Analysis for Lymphedema
BodyComp™ Analysis
Segmental BodyComp
™
Analysis
Lymphedema Prevention Program
Support
Frequently Asked Questions
IFU Documents
Quality & Regulatory Certificates
Terms & Conditions
Discontinued Products
Register Your Product
Request Support
About
Careers
Leadership
Newsroom
Patents
Request Quote
Quality & Regulatory Certificates
Request Support
Register Your Product
×
Certificates
HITRUST CSF
®
Certification v9.3
View PDF
Quality Management System: ISO 13485:2016 & EN ISO 13485:2016
View PDF
Quality Management System: Directive 93/42/EE on Medical Device, Annex II excluding Section 4
View PDF
Quality Management System: ISO 13485:2016; MDSAP
View PDF
Declarations
Declaration of Conformity – TGA
View PDF
Declaration of Conformity – SOZO
View PDF
Declaration of Conformity – Electrodes
View PDF
Declaration of Conformity – L-Dex U400
View PDF
Declaration of Conformity – SFB7
View PDF
Regulatory Clearances
510(k) clearance K190529 – SOZO PCM and Body Composition
November 2019
VIEW PDF
510(k) clearance K180126 – SOZO L-Dex
April 2018
View PDF
510(k) clearance K172507 – SOZO Heart failure
December 2017
View PDF
510(k) clearance K130338 – U400 L-Dex
May 2013
View PDF
510(k) clearance K052319 – SFB7 Body Composition
April 2006
View PDF
510(k) clearance K050395 – DF50 Body Composition
July 2005
View PDF