FDA.reportPublic FDA data

HindexRV

Primary DI
00860001651904
Brand
HindexRV
Company
HHS SYSTEMS, INC.
Model
1
Catalog number
SA7525HHS
Device description
The HindexRV® Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate and muscle activity) using sensors. The HindexRV® monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data.
Published
2019-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency
DPSElectrocardiograph
KZMDevice, Muscle Monitoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2
DPSElectrocardiographCardiovascular2
KZMDevice, Muscle MonitoringPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142551000QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC2015-04-16DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001651904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001651904008600016519048600016519040860001651904

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose invasive/noninvasive electrode kitA collection of dedicated electrodes intended to support a variety of electrophysiological measurements [e.g., electrocardiography (ECG), electroencephalography (EEG), electromyography (EMG), intraoperative monitoring (IOM), evoked potentials (EP)]. It includes both invasive (e.g., subdermal needle electrode) and noninvasive (i.e. skin surface) electrodes, and may include electrodes intended for stimulation; at least one reusable electrode is included. Supportive devices such as leads and adaptors may be included, however it does not include any monitors/monitoring devices. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
622298821
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001651911HindexRV1SA7525HHS2021-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00732094354959Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-06-09
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00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.BZQ2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DPS2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.BZQ2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.BZQ2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.BZQ2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZQ2026-06-02
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