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Standards of Conformity
GyroStim is designated by the FDA as a Breakthrough Medical Device. It integrates well with existing treatment modalities, provides access to treatment for lower functioning patients, and can provide a significant enhancement to clinical outcomes.
GyroStim has undergone rigorous third-party safety testing at
Intertek Testing Laboratories, Inc. for regulatory compliance and FDA clearance.
The table below provides information on GyroStim’s conformance with regulatory and FDA consensus standards related to design, development, and manufacturing of the GyroStim medical device.
Standard # & Edition | Standard Title |
|---|---|
AAMI HE 75:2009 | Human Factors Engineering – Design of Medical Devices, Section 9 – Usability Testing |
ISO 10993-1 Fifth Edition 2018-08 | Human Factors Engineering – Design of Medical Devices, Section 9 – Usability Testing |
ISO 10993-5:2009/(R)2014 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process |
ISO 10993-10 Third Edition 2010-08-01 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity |
IEC 63266-1:2015 | Medical Devices – Part 1: Application of usability engineering to medical devices |
IEC 60601-1-6 Edition 3.1 2013-10 | Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Usability |
ANSI/AAMI/IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medical electrical equipment—Part 1: General requirements for basic safety and essential performance |
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