GyroStim is FDA cleared and is designated by the FDA as a Breakthrough Medical Device.
April 27, 2022
GyroStim Receives FDA Clearance
On April 27, 2022, the FDA granted authorization for UltraThera to market the GyroStim as an FDA-cleared medical device for use in the treatment of balance disorders and vestibular dysfunction.
This accomplishment is the culmination of tremendous dedication and effort at UltraThera, and marks the beginning of a new era for GyroStim.
August 10, 2021
GyroStim Designated as
Breakthrough Medical Device
On August 10th, 2021, the FDA completed an extensive review process and designated GyroStim as a Breakthrough Medical Device, stating GyroStim has: “a reasonable expectation for providing more effective treatment relative to the current standard of care for balance disorders and vestibular dysfunction.”
The Breakthrough Device designation is a monumental accomplishment and a significant distinction that sets the device apart from all other devices in its category: the first and only device for the treatment of balance disorders and vestibular dysfunction the FDA has designated as a Breakthrough Medical Device.
Standards of Conformity
GyroStim has undergone rigorous third-party safety testing at Intertek Testing Laboratories, Inc. for regulatory compliance and FDA clearance.
A table (viewable below only on laptop or desktop) provides information on the device's conformance with regulatory and FDA consensus standards related to design, development, and manufacturing.
Standard # & Edition | Standard Title | FDA Requirement |
|---|---|---|
AAMI HE 75:2009 | Human Factors Engineering – Design of Medical Devices, Section 9 – Usability Testing | 5-57 |
ISO 10993-1 Fifth Edition 2018-08 | Human Factors Engineering – Design of Medical Devices, Section 9 – Usability Testing | 2-256 |
ISO 10993-5:2009/(R)2014 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process | 2-245 |
ISO 10993-10 Third Edition 2010-08-01 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | 2-174 |
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 | 5-89 |
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 | 19-8 |
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medical electrical equipment—Part 1: General requirements for basic safety and essential performance | 19-4 |