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HindexRV

FDA UDI

Class II (US FDA UDI)

by Hhssystems, LLC

Identity

Trade Name
HindexRV FDA UDI
Generic Name
Multi-purpose invasive/noninvasive electrode kit FDA UDI
Device Name
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. FDA UDI
Model / Reference
1 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
SA7525HHS FDA UDI
Primary DI / UDI-DI
00860001651904 FDA UDI
510(k) Number
K142551 FDA UDI
FDA Product Code
KZM FDA UDI
BZQ FDA UDI
DPS FDA UDI
GMDN Term
Multi-purpose invasive/noninvasive electrode kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1375 FDA UDI
868.2375 FDA UDI
870.2340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiographic electrode, single-usePsychophysiological biofeedback systemElectrocardiograph, professional, single-channelMulti-purpose invasive/noninvasive electrode kit

HindexRV by Hhssystems, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose invasive/noninvasive electrode kit.

Cleared under the same submission

K142551 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hhssystems, LLC

Sources (1)

  • FDA UDI 2e7830e3-23fa-49b7-bc97-e97016175d45 35 fields · synced May 31, 2026