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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
CLEARWATER CLINICAL LIMITED
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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