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510(k) Data Aggregation
K Number
K063872Device Name
KINESIA
Manufacturer
CLEVELAND MEDICAL DEVICES, INC.
Date Cleared
2007-04-06
(98 days)
Product Code
GYD
Regulation Number
882.1950Why did this record match?
Applicant Name (Manufacturer) :
CLEVELAND MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Kinesia is intended to monitor physical motion and muscle activity to quantify kinematics of movement disorder symptoms such as tremor and assess activity in any instance where quantifiable analysis of motion and muscle activity is desired.
Device Description
Kinesia™ is designed to monitor and record motion and electrical activity of muscle to quantify kinematics of movement disorders such as tremor for research and diagnostic purposes. The patient unit consists of a wrist module and ring sensor. Motion sensors including accelerometers and gyroscopes are integrated into a finger worn unit to capture three dimensional motions. The finger worn sensor unit is worn on a finger band and is connected to a wrist worn module by a thin flexible wire. The wrist module provides an input for two channels of electromyography, battery power, on board memory, and an embedded radio for real-time wireless transmission of the collected signals. The wrist module is worn on a comfortable, adjustable wristband.
The signals are communicated between the patient module and the computer unit using wireless technology based on 2.4-2.484 GHZ frequencies. Kinesia will consist of four major components:
1. Patient Module(consists of ring and wrist module)
2. Computer Unit
3. Electromyography Leads
4. Interface Software
1. The Patient Module includes a user worn ring and wrist module connected by a thin cable. The patient module monitors eight channels of data including three channels of accelerometers (linear acceleration sensors), three channels of gyroscopes (angular velocity sensors), and two channels of electrical muscle activity (EMG). The data can be transmitted in real-time over a wireless telemetry link to a computer or be stored in onboard memory. The wireless link can either transmit only (one-way) or transmit and receive (two-way). The basic functional feature of the component is to acquire signals from the subject, perform analog-to-digital conversion (when appropriate), encode, format, and transmit the signals to the Computer Unit or store data in on board memory. The Patient Module will operate on DC power from either rechargeable or replaceable batteries. The Patient Module includes a push button patient diary so the patient can indicate when they have taken their medication and when their symptoms are severe.
2. The Computer Unit will have the ability to only receive (one-way) or receive and transmit (two-way) data from the Patient Module. The basic functional feature of this component is to receive data packets from the patient unit, perform error detection and correction, and then send the data to the PC Operator interface where the data can be monitored in real time or stored and analyzed at a later time.
3: The Electromyography Leads provide an input for two channels of EMG recordings. The leads provide five standard snap connector inputs including two differential channels of EMG and a patient ground. The leads are connected to a lemo connector. The lemo connector attaches to the lemo input on the Patient Unit wrist module.
4. The Interface Software program consists of several software modules that allow the user to acquire, store, and review data as acquired by the hardware.
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K Number
K042039Device Name
FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120
Manufacturer
CLEVELAND MEDICAL DEVICES, INC.
Date Cleared
2004-11-17
(111 days)
Product Code
OLV, GWO
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
CLEVELAND MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Family of Crystal 20 Monitors are intended for monitoring and recording of physiological signals to aid in research and/or diagnostic purposes.
The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
Device Description
The Family of Crystal 20 Monitors® are designed to monitor physiological signals such as cardiovascular, neurological, and muscular for the purpose of research and diagnostic purposes. The Crystal 20 Monitor is a device that is programmable to the type of physiological signals being monitored such as EEG, EOG, EMG, ENG, ECG, PSG, airflow, pulse oximetry, respiratory effort, temperature, blood pressure, etc. The signals are communicated between the patient module and the computer unit using wireless technology based on frequencies such as but not limited to 902-928 MHz, 2.4 - 2.484 GHZ, Wireless Medical Telemetry Bands (WMTS), 608-614 MHz, 1395-1400 MHz, or 1429-1432 MHz. The communication between the patient module and computer unit can also be wired (instead of wireless). The Family of Crystal 20 Monitors® will consist of three major components:
1. Patient Module;
2. Computer Unit; and
3. Interface Software
1. The Patient Module can have up to 32 channels and the ability to either transmit only (one-way) or transmit and receive (two-way). The basic functional feature of the component is to acquire signals from commercially available electrodes / sensors that are attached to the subject, perform analog-to-digital conversion (when appropriate), encode, format, and transmit the signals to the Computer Unit. The Patient Unit will also have on-board memory capability that will permit the physiological data to be stored inside the patient unit. The Patient Module will contain no-touch connectors to enable connections to commercially available electrodes / sensors.
2. The Computer Unit will have the ability to only receive (one-way) or receive and transmit (two-way). The basic functional feature of this component is to receive data packets, performs error detection and correction, and then sends the data to the PC Operator interface where the data can be monitored in real time or stored and analyzed at a later time.
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K Number
K013863Device Name
CRYSTAL MONITOR MODEL 16
Manufacturer
CLEVELAND MEDICAL DEVICES, INC.
Date Cleared
2002-02-19
(90 days)
Product Code
OMC, OLV
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
CLEVELAND MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Crystal Monitor® Model 16 is intended for wireless monitoring and recording of physiological signals to aid in research and/or diagnostic purposes.
The device is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
Device Description
The Crystal Monitor Model 16 is an eight-channel, programmable, wireless data acquisition system intended to monitor and record physiological signals. Any channel can be programmed to monitor any physiological signal. Harnesses connect electrodes or sensors from the patient to the patient unit. The patient unit, worn by the patient, acquires, amplifies, and digitizes physiological signals. These signals are then transmitted by radio frequency to a computer unit connected via a serial port to a personal computer (PC). The data is then displayed in real-time and can be stored on the PC.
The Crystal Monitor Model 16 incorporates state-of-the-art wireless technology for viewing and recording physiological signals such as EEG, EKG, EMG, and EOG. This 8channel monitor is the most unobtrusive, flexible, and convenient way of measuring and transmitting physiological signals. Subjects can now be untethered during studies while real time data is collected and displayed. The Crystal Monitor Model 16 wireless physiological signal monitor consists of a Transmitter (also called the Patient Unit), a Receiver Assembly (a Receiver [also called the Computer Unit], receiver cable, and power supply), accessories (Universal Differential Harness, mounting band, electrolyte gel, screwdriver, batteries, and Test Pack), and a PC Operator Interface Software program.
The Patient Unit collects signals from electrodes attached to the subject, performs analogto-digital conversion, encoding, formatting, and transmitting of all signals. The signals are transmitted via a radio transmitter. The Computer Unit receives the transmitted data packets, performs extensive error detection and correction, and then sends the data through a Receiver cable to the PC Operator interface where the data can be stored, monitored in real time, or analyzed at a later time.
The Crystal Capture program consists of several software components that allow the user to acquire, store, and view physiological data as acquired by the Crystal Monitor Transmitter. The software provides a simple graphical interface for setting up and managing data acquisition. The Crystal Configuration Wizard allows customization of the number of input channels (1-8), ranges (micro- to millivolts), and sampling rate. Configurations can be saved allowing the user to program the Crystal Monitor for numerous applications.
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K Number
K001110Device Name
CRYSTAL-EEG MODEL 15
Manufacturer
CLEVELAND MEDICAL DEVICES, INC.
Date Cleared
2000-07-05
(90 days)
Product Code
OMC
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
CLEVELAND MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970672Device Name
CRYSTAL-EEG MODEL 10 (MODEL 10)
Manufacturer
CLEVELAND MEDICAL DEVICES, INC.
Date Cleared
1997-05-22
(87 days)
Product Code
OMC
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
CLEVELAND MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Crystal-EEG Model 10 is a mobile, intermediate range, wireless EEG system intended to be used for measuring and transmitting electroencephalogram (EEG) signals.
Device Description
The Crystal-EEG Model 10 is a mobile, intermediate range, wireless, EEG system used for measuring and transmitting bioelectric signals such as electroencephalogram (EEG). It consists of a Transmitter, a Receiver Assembly which consists of the receiver, receiver cable, and power supply; the Software; Patient Accessories consisting of EEG Electrodes, headband, battery, and battery connector; and a PC Operator Interface which consists of Operator Interface Software, Transmitter Set-up Cable, and a Personal Computer (optional).
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K Number
K964690Device Name
LIBERTY VALVE
Manufacturer
CLEVELAND MEDICAL DEVICES, INC.
Date Cleared
1997-03-21
(119 days)
Product Code
KNX
Regulation Number
876.5250Why did this record match?
Applicant Name (Manufacturer) :
CLEVELAND MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Liberty Valve is intended to allow individuals in a wheelchair to empty their own urine collection leg bag, which may be connected to either an indwelling or non-indwelling catheter, provided the individual possesses the ability to make gross arm and hand movements.
Device Description
The Liberty Valve consists of a switch box, a solenoid valve with electrical connection, a fuse, battery leads with wiring, and tubing with the necessary connections for attachment to the leg bag and valve. The device is to be mounted to the wheelchair permanently with the clamps and wire ties provided. The switch box regulates the power from the battery which opens the solenoid valve the urine collection leg bag to drain.
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K Number
K962591Device Name
FOOT WEIGHT ALARM
Manufacturer
CLEVELAND MEDICAL DEVICES, INC.
Date Cleared
1996-12-04
(155 days)
Product Code
IRN
Regulation Number
890.5575Why did this record match?
Applicant Name (Manufacturer) :
CLEVELAND MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Foot Weight Alarm is intended for use in the weight bearing training of patients with various orthopedic and neurological disabilities, such as malunion fracture, amputation, and cerebral vascular accident. The Foot Weight Alarm helps train patients by limiting the amount of force placed on the leg or helping a patient to reach a set amount of force in order to facilitate the return to normal gait pattern,
Device Description
The Foot Weight Alarm is a foot shaped insole device to fit inside the patient's shoe to warn the patient when they are putting too little or too much weight on a limited weight bearing foot. It consists of an Insole, a Shoe Pouch which laces to the shoe, a foot unit which fits in the Shoe Pouch and connects to the Insole, a data cable that is used by a health care professional to program the Foot Weight Alarm unit; and Foot Weight Alarm Calibration System used by the health care professional to program the Foot Unit.
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