Where can I find a GyroStim?

GyroStim is in use in eight countries around the world. Download a current contact list for GyroStim facilities at http://www.gyrostim.com/locations

Is GyroStim FDA approved?

GyroStim is FDA-cleared for use in the treatment of balance disorders and vestibular dysfunction.

Standards of Conformity

Regulatory Conformance

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