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510(k) Data Aggregation
K Number
K010270Device Name
TREMOROMETER
Manufacturer
FLEXABLE SYSTEMS, INC.
Date Cleared
2001-07-25
(177 days)
Product Code
GYD, GWQ
Regulation Number
882.1950Why did this record match?
Applicant Name (Manufacturer) :
FLEXABLE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tremorometer is designed to be used to measure and record tri-axial readings of a patient's tremor motions, to optionally combine the three axis tremor information into a single measurement of total tremor movement by a proprietary algorithm that eliminates some of the rotational, orientation and other artifacts, to display the information graphically, and to transfer the data to a PC for further analysis, display, printing or storage.
Device Description
The Tremorometer is a system designed to improve the measurement and quantification of tremor in human patients regardless of the underlying etiology of the tremor. It consists of a Tremor Sensor, a microcomputer and programs to operate the microcomputer. The federally registered trademark "Tremorometer" is intended to cover the system comprised of these three parts.
The Tremor Sensor is a three axis accelerometer that attaches to a patient's finger and transmits the tri-axial tremor measurements to the Tremorometer. Other acceleration measuring devices could be used in place of the current Tremor Sensor provided they met the sensitivity, accuracy, resolution and range of the current device.
The microcomputer is the FlexLab™ manufactured by FlexAble Systems, Inc. that is used in a number of industrial applications. It is a battery powered, hand-held, self-contained, programmable device. Other microcomputers with the capability of reading the pulse width modulated signals generated by the Tremor Sensor could be used in place of the FlexLab.
The programs range from general system software to control the keypad and LCD displays to proprietary algorithms that process the tremor data. The code is written in 'C' and could be easily ported to another microcomputer.
The FlexLab has a keypad and LCD display for interaction with the user. General purpose software provides for setting and reading date and time from a clock/calendar IC; bi-directional serial communication using Xmodem CRC and CSum protocols at selectable Baud rates; display and control of system settings; and more. Custom software designed specifically for the tremor measuring and processing application include routines to take precisely timed measurements from the Tremor Sensor; perform calibration of the Tremor Sensor using Earth's gravity as a reference; run automated, timed series of tests; process and store data with check digits to insure data integrity; display the data graphically on the LCD; generate and maintain record headers; control the transmission of complete records to a PC; clear records; download user generated test lists; and more.
The three-axis reading may be combined into a single composite measure of total movement by proprietary algorithms that eliminate some of the non-tremor signals such as rotational components, orientation relative to Earth's gravity and other artifacts.
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