ElectroFluidGraph

by Akern USA, LLC

510(k) K091369

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

510(k) K091369↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK091369	Date14 Oct 2009Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K091369
FDA Product Code: MNW

Device Class: Class II
Regulation: 21 CFR Part 870.2770
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ElectroFluidGraph is a Body Composition Analyzer, designed to measure and estimate key physiological parameters. It assesses fat-free mass, fat mass, total body water, and extracellular water using bioelectrical impedance technology.

This device is intended for single-use in clinical or research settings and is classified as a Class II medical device under FDA regulation 870.2770. Supplied as a reusable analyzer with disposable electrodes, it requires no sterilization and operates in non-MRI environments. Authorized under FDA 510(k) clearance (K091369), it is intended for generally healthy adults aged 21 to 87 years.