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510(k) Data Aggregation
K Number
K220231Device Name
GyroStim
Manufacturer
UltraThera Technologies, Inc.
Date Cleared
2022-04-27
(90 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Product Code :
LXV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GyroStim is intended to assist in the treatment of balance disorders and vestibular dysfunction in adult patients, age 18 and older, up to 400lb. It is intended to be used by a trained medical professional as prescribed by physician in a clinical environment.
Device Description
GyroStim is an AC powered computer-controlled multi-axial positional and rotational chair. The device consists of a patient chair mounted within a rotational frame assembly that is capable of rotating in the pitch and yaw axes. The rotational frames are automated with computer-controlled drive systems capable of executing preprogrammed positional and rotational motion profiles. The system provides clinicians with a safe and efficient means for administering a wide range of specific positional and rotational motions for inducing stimulation of the vestibular system.
GyroStim operational software runs on a pc-based desktop computer. The software can capture, monitor, and display the patient's subjective response to each run. The response data may be used by the clinician for clinical decision support (CDS) to assist with progress evaluation, for profile selection and rate of therapy advancement, for individualizing therapy sessions, and for monitoring and preventing overstimulation.
Patient data is collected and stored and may be accessed for graphing, analysis, and reports.
The software includes libraries of prewritten profiles. A library of pre-written positional profiles located on the RUN BPPV page contains a collection of profiles for executing commonly used canalith repositioning maneuvers. A library of pre-written motion profiles located on the RUN GyroStim page contains a collection of profiles for executing motion induced vestibular stimulation.
Specifically, the library of motion profiles contains 30 levels of motion induced vestibular stimulation intensity, ranging from Level 1 to Level 30. The lowest level of motion induced vestibular stimulation intensity is Level 1, which rotates at a rate of 1 revolution per minute (RPM) or 0.016667 Hz. The highest level of motion induced vestibular stimulation intensity is Level 30. which rotates at 30 RPM or 0.5Hz. The intensity of the 30 levels differs and increments linearly at a rate of 1 RPM or 0.01667Hz per level; i.e.. Level 1 rotates at 1 RPM or 0.01667 Hz, Level 2 rotates at 2 RPM or 0.03334 Hz, Level 3 rotates at 3 RPM or 0.05 Hz, and so on up to Level 30 which rotates at 30 RPM or 0.5 Hz. Additionally, each of the 30 Levels offer a selection of run durations at 15 seconds (s), 30s, 60s, and 180s.
When configured with the integrated patient transfer system, GyroStim provides accessibility to the large population of patients with moderate to severe mobility challenges, many of whom are limited or unable to engage in the existing standard of care for balance disorders and vestibular dysfunction.
The GyroStim assembly, operational software, and libraries of profiles provide clinicians with a safe, effective, and efficient medical device for assisting in the treatment of balance disorders and vestibular dvsfunction.
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K Number
K200529Device Name
Orion
Manufacturer
Interacoustics A/S
Date Cleared
2020-08-12
(163 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Product Code :
LXV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Orion rotary chair is an optional accessory for VisualEyes 515 eye movement recording systems.
The VisualEyes™ system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. VNG testing evaluates nystagmus using goggles mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information can then be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for videonystagmography is five years of age and above.
Device Description
The Orion is a rotary chair designed to assess the Vestibular Ocula Reflex (VOR).
Orion rotary chair includes these three variants
- Orion Reclining
- Orion Auto Traverse
- Orion Comprehensive .
The Orion is considered an accessory to vestibular examination system software designated VisualEyes 525 and VisualEyes 515 manufactured by Interacoustics (FDA 510(k) K200534).
The Orion is an update of the System 2000 by Micromedical ((FDA 510(k) ID K922037).
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K Number
K192652Device Name
TRV
Manufacturer
Interacoustics A/S
Date Cleared
2020-05-27
(246 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Product Code :
LXV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TRV is intended to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo.
Device Description
The TRV is a multi-axial chair that can rotate 360° around both the horizontal and vertical axes. With the patient secured by a four-point harness, a head mount, a leg strap, and shoulder pads, an examiner is able to rotate the patient around the plane of each of the 6 semicircular canals and hold the patient in any position for detailed examination of the semicircular canals. The TRV chair is manually handled by the healthcare professional. The axes of rotation are lockable in preset positions. The primary axis has a battery-powered electromagnetic lock controlled by a footswitch and the secondary axis is manually locked with a mechanical lever. A mechanical system with an adjustable counterweight ensures that the weight of the chair and the patient are balanced during the maneuvers.
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K Number
K183661Device Name
ClearEdge Balance System
Manufacturer
Quadrant Biosciences
Date Cleared
2019-10-22
(299 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Product Code :
LXV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearEdge® Balance System is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers, physical therapists, chiropractors, nurses and physicians. The ClearEdge® Balance System can be used wherever compatible Android mobile operating devices can be used.
Device Description
The ClearEdge® Balance System is a mobile software system that analyzes balance through measurements of postural sway. The System is comprised of application software, and accompanying hardware consisting of a mobile computing device, proprietary sensor, balance pad, and friction pad. The test data is collected, uploaded to a HIPAA compliant server, analyzed by Motion Intelligence developed algorithms and presented in report form for clinician's review. The reports indicate how a subject's balance score may have changed between testing sessions, and whether the measured change is likely due to measurement error and normal human variation in performance of the selected balance stance or a real change in performance caused by an external factor.
Using proprietary software on an Android tablet and the Edge Sensor, the ClearEdge Balance System tests balance by administering eight select balance stances.
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K Number
K190735Device Name
EQ Balance
Manufacturer
Highmark Innovations Inc. DBA Highmark Interactive
Date Cleared
2019-08-16
(148 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Product Code :
LXV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EQ Balance is intended to assess body tilt as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses and physicians. Interpretation of EQ Balance results should only be made by a healthcare professional, as part of a multifaceted assessment of balance. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. EO Balance should be used in an indoor setting free from obstructions and free from excessive noise or visual distractions. EQ Balance should be only be used as directed by your healthcare practitioner. EQ Balance may be used on mobile devices running iOS or Android operating systems.
Device Description
EQ Balance is a mobile balance test to be used on mobile phone and tablet devices with iOS version 10.3 or later, or Android OS version 6 or later. EQ Balance measures balance using the accelerometer within the device.
EQ Balance utilizes an algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer. Balance is measured during a series of stances with the mobile device held to the chest by the user. Users follow the step-by-step voice guidance that runs after launching the app during the entirety of the test to ensure consistency in obtaining balance measures. EQ Balance does not function as a diagnostic test, and EQ Balance results should be interpreted by qualified individuals only.
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K Number
K173669Device Name
K-D Balance
Manufacturer
King-Devick Technologies, Inc.
Date Cleared
2018-04-02
(123 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Product Code :
LXV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
K-D Balance is an objective balance assessment tool and is intended to be used for individuals for whom a balance measurement is a desired outcome. K-D Balance is intended for use to assess balance performance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified or licensed in their state to prescribe and use balance devices including but not limited to athletic trainers and coaches, physical therapists, nurses, physicians, and other health care providers. Patients with could affect balance include, but are not limited to, vestibular dysfunction, nausea, headaches, orthopedic injury, inner ear infection or dysfunction, neurological conditions, head injury, medication side effects, dehydration and fatigue. K-D Balance can be used wherever an iOS mobile operating device is available. K-D Balance may only be used by health care professionals.
Device Description
K-D Balance is a mobile balance test to be used on the 6th generation iPhone or iPod touch with iOS versions 9.0 or later. K-D Balance measures balance using motion sensors already built-in to the iPhone or iPod touch devices. K-D Balance utilizes a proprietary algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer. Balance is measured during a series of stances with the mobile device secured to the subject with a device holder. Health care professionals follow the step-by-step voice guidance that runs after launching the app during the entirety of the test to ensure consistency in obtaining balance measures. K-D Balance does not function as a diagnostic test, and K-D Balance results should be interpreted by healthcare professionals only.
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K Number
K121590Device Name
VESTIBULAR ANALYSIS APPARATUS
Manufacturer
CAPACITY SPORTS, LLC
Date Cleared
2012-09-20
(112 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Product Code :
LXV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sway™ Balance System is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses and physicians. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. The Sway™ Balance System can be used wherever an iOS mobile operating device is available.
Device Description
The Sway Balance™ System is a mobile measurement system that analyzes balance through thoracic sway, using the built in accelerometer of a mobile device. The Sway Balance™ System is a stand-alone mobile operating system software application that does not include any peripheral hardware add-ons.
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K Number
K102364Device Name
NYDIAG 200
Manufacturer
INTERACOUSTICS A/S
Date Cleared
2010-12-23
(125 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Product Code :
LXV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nydiag 200 rotary chair is an optional accessory for the Interacoustics eye movement recording systems. The rotary chair is used to elicit Vestibulo-Ocular Reflexes in patients aged 2 years or older who weigh less than 135 kg / 300 lbs who are being tested for bilateral or unilateral lesions in the peripheral vestibular organs.
Device Description
The Nydiag 200 is a rotation chair, including a chair unit and a motor pedestal unit. The Nydiag 200 is controlled by software. The rotating chair is an optional accessory and is used for stimulation of the patients balance organs. The chair is supplied from the mains and controlled from a computer through an USB connection. The chair unit includes the chair itself attached to a frame assembly, seat belts and other restraints, patient discomfort signal device and goggle connections (Firewire and USB). The pedestal includes a power unit and motor and gearing units.
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K Number
K082634Device Name
VERTIGONE BPPV GOGGLE
Manufacturer
VERTIGONE, INC.
Date Cleared
2009-04-07
(209 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Product Code :
LXV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VertiGONE goggle is indicated for the treatment of Benign Paroxysmal Positional Vertigo (BPPV). The VertiGONE goggle guides the practitioner to move the patient's head accurately through the Epley, or canalith repositioning maneuver.
Device Description
The VertiGONE BPPV Goggle is a head mounted medical device worn by the patient. The VertiGONE Goggle is designed as a non-intrusive device with nonsubstantial risk to the subjects. The subject device consists of a molded plastic goggle, an elastic strap to secure the goggle to the head, and a visual reference platform including two visual reference mechanisms. The VertiGONE Goggle provides a visual reference platform for the practitioner to guide the patient to accurately conduct the Epley, or canalith repositioning, maneuver. When using the device, the patient and/or the practitioner are each provided with visual references. Thus, the practitioner can help the patient to complete the Epley maneuver more accurately.
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K Number
K081602Device Name
DIZZYFIX
Manufacturer
CLEARWATER CLINICAL LIMITED
Date Cleared
2008-09-19
(105 days)
Product Code
LXV
Regulation Number
N/AWhy did this record match?
Product Code :
LXV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DizzyFIX is indicated for the treatment of vertigo where a physician has diagnosed posterior canal BPPV and recommended one of the exercise variations which are used to treat this type of vertigo. The DizzyFIX should be used as a component to assist in correct performance of therapeutic exercises for the treatment of vertigo.
Patients with a diagnosis of Posterior Canal Benign Paroxysmal Positional Vertigo (BPPV) who exhibit:
a. Momentary spinning dizziness,
b. Which lasts seconds to minutes,
c. Which is associated with position change
Device Description
The DizzyFIX is a small, non powered, non-sterile head worn device which can assist in the performance of the treatment exercises for vertigo. The DizzyFIX is a device which assists in the performance of a correct "Particle Repositioning Maneuver". Whether being used by a patient at home, a doctor or other health professional, this device helps to treat BPPV by encouraging the correct angles and duration for conducting both diagnostic and treatment exercise maneuvers. With the DizzyFIX, persons who suffer from BPPV can repeat the repositioning exercises at home as often as needed to achieve resolution of symptoms.
The DizzyFIX consists of a specially curved acrylic tube containing a non-toxic viscous fluid and a bead. The entire device is about the size of a person's fist and weighs only a few hundred grams. Factors such as fluid viscosity and tube shape were carefully designed so that motion of the bead within the tube guides the patient accurately through the series of vestibular exercises.
The device clips onto the mid-brim of any hat such that it is visible to the wearer. Beginning with the bead at one end of the tube, the patient tilts his or her head at appropriate angles and time intervals to slowly move the bead to the other end of the tube. Thus, there is real-time feedback to the patient. If the bead arrives at the other end of the tube, the exercise maneuvers have been performed correctly. The exercise maneuver can be repeated as often as needed.
The DizzyFIX device consists of a transparent tube filled with mineral oil. The device contains a bead that freely travels within the mineral oil. The tube is permanently sealed at both ends. The device has a clip which facilitates its attachment to the included hat such that it is visible to the user. The hat has a strap such that it is affixed snugly to the users head. The device, tube and bead have characteristics such that only by performing a correct vestibular exercise might the bead move from one end of the tube to the other.
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