K091369 is an FDA 510(k) clearance for the ELECTROFLUIDGRAPH. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.
Submitted by Akern USA, LLC (Greenwood Village, US). The FDA issued a Cleared decision on October 14, 2009 after a review of 159 days - an extended review cycle.
This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.2770 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.
View all Akern USA, LLC devices
NCT00956917
Completed
Interventional
Industry-sponsored
Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition
Comparison of Impedance Components and Estimated Body Composition Variables Determined by Using Bioelectrical Impedance Devices Manufactured by Akern SRL and RJL Systems
| Condition studied |
Body Composition Measurement |
| Study design |
Crossover |
| Eligibility |
All sexes
· 16 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Luca Gatteschi, MD |
| Sponsor |
Akern USA LLC
(industry)
|
Started 2009-05-01
→
Primary completion 2009-06-01
Primary outcome
Resistance (R) - (ohms)
Secondary outcome
Fat Free Mass (FFM)
Study completed - no results published.
This trial concluded in 2009 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov