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CloudHRV System (100-01-001)

by Inmedix, Inc.

510(k) K241217

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241217 Date16 Jan 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 CloudHRV System (100-01-001) is an electrocardiograph (product code DPS) designed for medical-grade heart rate variability (HRV) analysis. It evaluates autonomic nervous system activity by assessing sympathetic and parasympathetic function through ECG-based measurements.

The device acquires approximately five minutes of 3-lead ECG data using four electrodes placed on wrists and ankles, transmitting raw signals to an Inmedix cloud service. It employs proprietary algorithms to calculate HRV indices across time-domain, geometric, and frequency-domain metrics, with results displayed on a tablet for clinician review. Supplied as a reusable medical device, it holds an FDA 510(k) clearance (K241217) under traditional review, classified as Class II with special controls.

Other devices from Inmedix, Inc.