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Found 7 results
510(k) Data Aggregation
K Number
K063447Device Name
INSIGHT DISCOVERY
Manufacturer
FASSTECH
Date Cleared
2007-08-16
(274 days)
Product Code
IKN, HCC, REG
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
FASSTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To measure bilateral differences in surface EMG along the spine
To measure surface EMG along the spine during functional tasks
To measure bilateral differences in skin temperature along the spine
To measure Range of Motion of the three spinal regions
To measure patient self-reported pressure sensitivity in joints and muscles
To measure Heart Rate
To chart patient progress during the course of treatment
Device Description
The Insight Discovery is a non-invasive, multi-modality physiologic monitoring device. The Insight Discovery contains the following six sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) algometer used to measure patient self-reported pressure sensitivity, and (4) heart rate sensor to measure heart rate, (5) an inclinometer used to measure end-point range of motion, and (6) a wireless version of the inclinometer.
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K Number
K033452Device Name
CWAS 1000
Manufacturer
FASSTECH
Date Cleared
2003-11-28
(29 days)
Product Code
IKN
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
FASSTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The device measures several physiologic signals, and its software generates a report.
The CWAS 100 measures the following physiologic signals:
- Bilateral differences in surface EMG along the spine
- Heart Rate
- Skin temperature
- Galvanic Skin Resistance
- Body fat percentage in subjects eighteen years and older
Device Description
The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The CWAS 100 contains the following five sensor types: (1) surface EMG, (2) IR Plethsmograph, (3), Skin temperature, (4) Galvanic Skin Resistance and (5) IR Body Composition Analyzer.
Hardware: The CWAS 100 hardware consists of an instrument console and five different sensor types. All five sensor types plug directly into the front panel of the CWAS 100 Instrument Console. The CWAS 100 Console is powered via a UL2601 listed power supply. The Instrument Console is connected to a personal computer (IBM compatible) via an isolated USB port connection.
Software: The CWAS 100 software displays real-time surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, allowing the user to ensure that readings are stable prior to data collection. The CWAS 100 software allows the user to: (1) enter patient information, (2) record surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, and (3) print out a data report which summarizes the results of the above sensors as well as blood pressure, vital lung capacity, and chest, leg and back strength, which are data provided by the user.
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K Number
K023209Device Name
INSIGHT MILLENNIUM III
Manufacturer
FASSTECH
Date Cleared
2003-10-10
(379 days)
Product Code
IKN, HCC
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
FASSTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- To measure bilateral differences in surface EMG along the spine
- To measure surface EMG along the spine during functional tasks
- To measure bilateral differences in skin temperature along the spine
- To measure Range of Motion of the three spinal regions
- To measure patient self-reported pressure sensitivity in joints and muscles
- To measure Heart Rate
- To chart patient progress during the course of treatment
Device Description
The Insight Millennium III is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium III contains the following five sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) inclinometer used to measure end-point range of motion, (4) algometer used to measure patient self-reported pressure sensitivity, and (5) heart rate sensor to measure heart rate.
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K Number
K011964Device Name
INSIGHT MILLENNIUM PLUS
Manufacturer
FASSTECH
Date Cleared
2001-09-20
(87 days)
Product Code
HCC, HRW
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
FASSTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To measure bilateral differences in surface EMG along the spine
To measure surface EMG along the spine during functional tasks
To measure bilateral differences in skin temperature along the spine
To measure Range of Motion of the three spinal regions.
To measure patient self-reported pressure sensitivity in joints and muscles
To chart patient progress during the course of treatment
Device Description
The Insight Millennium Plus is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium Plus contains the following four sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) inclinometer used to measure end-point range of motion, and (4) algometer used to measure patient self-reported pressure sensitivity.
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K Number
K011983Device Name
INSIGHT GENESIS
Manufacturer
FASSTECH
Date Cleared
2001-08-30
(65 days)
Product Code
HCC
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
FASSTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To measure bilateral differences in surface EMG along the spine
To measure surface EMG along the spine during functional tasks
To chart patient progress during the course of treatment
Device Description
The Insight Genesis is a non-invasive, single-modality physiologic monitoring device. The Insight Genesis contains two surface EMG sensors used to measure muscle activity.
Hardware: The Insight Genesis hardware consists of an instrument console and two surface EMG sensors. The Insight Genesis will plug directly into the UL-2601 listed wall mounted power supply. The Instrument Console is powered by a computer (IBM compatible) via an isolated serial port connection.
Software: The Insight Genesis software displays real-time surface EMG, allowing the user to ensure that readings are stable prior to data collection. The Insight Genesis software allows the user to: (1) collect and store surface EMG, (2) view and analyze surface EMG, and (3) print out reports.
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K Number
K990778Device Name
INSIGHT MILLENNIUM
Manufacturer
FASSTECH
Date Cleared
1999-06-03
(86 days)
Product Code
HCC
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
FASSTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- To measure bilateral differences in surface EMG along the spine .
- To measure surface EMG along the spine during functional tasks .
- To measure bilateral differences in skin temperature along the spine .
- . To measure Range of Motion of the three spinal regions
- . To chart patient progress during the course of treatment
Device Description
Not Found
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K Number
K961212Device Name
SPINAL TOUCH
Manufacturer
FASSTECH
Date Cleared
1996-06-12
(76 days)
Product Code
KQX
Regulation Number
888.1500Why did this record match?
Applicant Name (Manufacturer) :
FASSTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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