HindexRV SA7525HHS

GUDID 00860001651911

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.

HHS SYSTEMS, INC.

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• Primary Device ID: 00860001651911
• NIH Device Record Key: d9d77bc8-9a29-473a-bc8a-237e0636d9f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HindexRV
• Version Model Number: 1
• Catalog Number: SA7525HHS
• Company DUNS: 622298821
• Company Name: HHS SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001651911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142551

FDA Product Code

• KZM: Device, Muscle Monitoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-28
• Device Publish Date: 2021-01-20

On-Brand Devices [HindexRV]

• 00860001651904: The HindexRV® Monitoring System is a physiological monitoring device that collects and transmit
• 00860001651911: The HindexRV® Monitoring System is a physiological monitoring device that collects and transmit