← Back to catalogue

Stress Guard Model HERDEV1

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K004008

by Herbo Medex International, Inc.

Identifiers

510(k) Number
K004008 FDA 510(k)
FDA Product Code
GZJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5890 FDA 510(k)
Regulation Number
882.5890 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Stress Guard Model HERDEV1 is a medical device classified under the product code GZJ, intended for use in neurological applications. It is designed to provide stress monitoring and management, likely through non-invasive methods to assess physiological responses related to neurological function or stress levels.

This device is supplied by Herbo Medex International, Inc. and is cleared by the FDA under a 510(k) submission (K004008) as substantially equivalent to a predicate device, with regulatory compliance also noted under the Medical Device Regulation (MDR). It is intended for single-use or reusable applications in clinical settings, though specific sterility or reuse instructions are not detailed in the provided data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Herbo Medex International, Inc.

Sources (2)

  • FDA 510(k) K004008 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026