FDA Status

FDA-cleared: K220231
FDA-designated as a Breakthrough Medical Device

Indication For Use Statement:

GyroStim is intended to assist in the treatment of balance disorders and vestibular dysfunction in adult patients, age 18 and older, up to 400lbs. It is intended to be used by a trained medical professional as prescribed by physician in a clinical environment.

FDA Recognition: A Historic Milestone

GyroStim is only the 47th medical device in FDA history to receive both 510(k) clearance and the prestigious Breakthrough Device designation—a rare dual recognition that firmly establishes GyroStim as the undisputed leader in vestibular rehabilitation therapy.

This distinction underscores GyroStim’s clinical significance and affirms that its advanced, technology-assisted capabilities far exceed the limitations of outdated manual therapies and any other device in its category. It marks the beginning of a new era in the treatment of vestibular dysfunction—one defined by faster, safer, and more effective outcomes.

Since 2010, GyroStim’s innovative design and intelligent, multi-axis robotic technology have maintained a perfect safety record while consistently delivering superior patient outcomes. It has set a new standard in healthcare—and is leading the future of technology-assisted multimodal neurorehabilitation.

August 10, 2021

FDA Designates GyroStim as a Breakthrough Medical Device

Q200178/S002

On August 10th, 2021, following an extensive review process, the FDA granted GyroStim 'Breakthrough Device' designation. In its decision, the FDA stated that 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 achievement and a powerful distinction that sets GyroStim apart from all other devices in its category. It is the first and only medical device for the treatment of vestibular dysfunction to receive this prestigious breakthrough device designation from the FDA.

Ultimately, only about 10% of medical devices designated with Breakthrough Device status withstand the FDA’s rigorous review to also be granted marketing authorization—underscoring both the high standards of the FDA's Breakthrough Device program, and the exceptional clinical outcomes achievable only with the technological advantages of GyroStim.

April 22, 2022

GyroStim Receives
FDA Clearance

K220231

On April 27, 2022, the FDA granted UltraThera authorization to market GyroStim as an FDA-cleared medical device for treatment of vestibular dysfunction.

Vestibular dysfunction is a general indication that can result from a wide range of specific conditions that disrupt peripheral and or central processing of vestibular sensory information. Proper vestibular function is critical not only for balance and spatial orientation but also for cognitive performance and overall quality of life. Disruptions to vestibular processing are commonly associated with conditions such as concussion (mTBI), Autism Spectrum Disorder (ASD), stroke, Down Syndrome, cerebral palsy, MdDS, MS, Parkinson's Disease, and many others. Individuals affected by these and other conditions who present with symptoms of vestibular dysfunction may benefit from treatment with GyroStim therapy.

As stated in the IFU, GyroStim is intended to assist in the treatment of vestibular dysfunction which is considered to be a general indication. A medical device with a general indication for use can be used for treatment of a specific condition within the scope of its intended use, provided that the manufacturer's labeling and instructions for use are followed. Ultimately, as with any medical device, the healthcare provider must exercise their clinical judgement when considering whether the use of GyroStim for treatment of a specific condition is appropriate and within the scope of its intended use.

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 (not viewable with smartphone) provides information on the device's conformance with regulatory and FDA consensus standards related to design, development, and manufacturing.

Title	Long Description	Short Description
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
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

FDA Status

FDA-cleared: K220231

FDA-designated as a Breakthrough Medical Device

Indication For Use Statement:

FDA Recognition: A Historic Milestone

FDA Designates GyroStim as a Breakthrough Medical Device

GyroStim Receives FDA Clearance

Standards of Conformity

GyroStim Receives
FDA Clearance