top of page

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 GyroStim apart from all other devices in its category: GyroStim is 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.

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
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

GyroStim is Designed & Engineered for Safety

Safety is a driving force behind everything we do from design and development to manufacturing and applications.

Millions of rotations

The strongest testimonial for GyroStim safety is that there have been ZERO injuries as a result of device malfunction after millions of rotations at locations around the world. 

 

Fail-safe design

The GyroStim is engineered with a fail-safe design throughout so that should a malfunction occur, the chair operation will default to a safe state. This design includes numerous hardware and software interlocks that prevent or stop motion of the GyroStim if they are interrupted.

Redundant stop controls

Stop buttons are located on the handholds, giving the patient ultimate control and confidence knowing they can initiate a controlled stop and bring the GyroStim to home position. 

Stop buttons on the operator screen allow the operator to initiate a controlled stop to bring the GyroStim safely to home position.

 

An emergency stop button located at the operator station removes all power immediately from the rotation drive motors, allowing the GyroStim to glide to a stop in a safe upright position.

G-force safety

To put things into perspective, at GyroStim's maximum intensity and speed, it produces far less G-force than typical theme park roller coasters that are ridden by hundreds of thousands of people every day.

gyrostim-safety-features

Rigorous safety testing

In order to achieve FDA clearance, the GyroStim was required to undergo an extensive battery of electrical, mechanical, and safety regulatory testing.

GyroStim safety is engineerined in every step of design and manufacturing. 

bottom of page