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510(k) Data Aggregation
K Number
K130158Device Name
M-SCAN
Manufacturer
BIO-RESEARCH ASSOCIATES, INC.
Date Cleared
2013-07-25
(183 days)
Product Code
KZM
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
BIO-RESEARCH ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use; 2 channel, hand held, mobile EMG amplifier
1. To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
2. To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
3. To determine the degree of relaxation (intra-patient) of 2 muscles at rest
4. To measure relative (intra-patient) levels of activity of 2 muscles during a function act
Device Description
The M-Scan is a 2-channel, portable, battery operated electromyographic amplifier which includes: a) two (2) identical high-gain differential input amplifiers, b) two (2) buffer amplifiers, c) two (2) full wave rectifiers, and d) two (2) integrators. The overall amplification of the M-Scan is calibrated to 2500. The bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3dB). The common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz). The M-Scan does not include isolated power converter since it is battery operated, portable, and does not interface with any external equipment (it is never connected to the a-c line). Only three (3) functions are provided by the M-Scan: 1) amplification, 2) bandwidth limiting, and 3) integration of the signal for the integrated display.
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K Number
K082927Device Name
BIOEMG III
Manufacturer
BIO-RESEARCH ASSOCIATES, INC.
Date Cleared
2009-02-06
(128 days)
Product Code
KZM
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
BIO-RESEARCH ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use: 8 channel EMG amplifier
1. To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric
2. To clinically monitor up to eight different muscles as an aid in the diagnosis and treatments evaluation by recording the electrical activity of muscles of the stomatognathic system
3. To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest
4. To measure relative (intra-patient) levels of activity of several muscles during a functional act
Indications for Use: 2 channel JVA amplifier
1. To record and display sounds / vibrations from the temporomandibular joints
2. To aid the clinician in his analysis of a joint sound/vibration by allowing him/her to see the waveform in various standard plots (together with K981563)
3. To aid the clinician in comparing a patient's current stand plots to previous recordings before, during and after treatment
4. To provide numerical values that can be used to quantify the physical characteristics of the sounds / vibrations, allowing intra-patient comparisons (only) by the clinician
Device Description
The BioEMG III is a multi-channel electromyographic amplifier which includes; a) eight (8) identical high-gain differential input amplifiers, b) eight (8) identical opto-coupler isolation units and c) eight (8) ourput buffer amplifiers. The overall amplification of the BioEMG III is calibrated to 5000X. The bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3 dB). The common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz). The BioEMG III includes an isolated power converter that converts non-isolated +5 vdc into isolated + 5 and - 5 vdc. It may be connected to a personal computer through an analog to digital converter. Only three (3) functions are provided by the BioEMG III; I) amplification, 2) bandwidth limiting and 3) electrical isolation of the patient.
Analogous to the BioEMG II, the BioEMG III also incorporates two (2) additional inputs for recording vibrations from the left and right temporomandibular joints. They consist of: a) two (2) identical high-gain amplifiers and b) two (2) output buffer amplifiers. For these inputs no isolation is required because there is no electrical connection to the patient. The amplification is calibrated to 5000X and the bandwidth filtering is set from 30 Hz to 1000 Hz (± 3dB). These channels are also powered from an external +5 vdc non-isolated source, which is converted to +5 and -5 vdc. The vibration signals may also be connected to a personal computer through an analog to digital converter. The two (2) functions performed by these "JVA" channels include: 1) amplification and 2) bandwidth limiting.
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K Number
K061799Device Name
QUADRATENS, MODEL QT-42
Manufacturer
BIO-RESEARCH ASSOCIATES, INC.
Date Cleared
2006-08-28
(63 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BIO-RESEARCH ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QuadraTENS is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
Device Description
The QuadraTENS Model QT-42 is a 2 channel version of the BioTENS with the addition of a burst mode. Like the BioTENS, it is also intended to be used by or on the order of a licensed practitioner. The burst mode has been added specifically because a single stimulus is sometimes insufficient. By adding a second channel, the QuadraTENS Model QT-42 can be applied simultaneously to another separately enervated area on the same patient. The low frequency stimulation (1.0 Hz rate) of the QuadraTENS Model QT-42, the same as its predecessor BioTENS, is applied to a patient through surface electrodes. The Unit is powered by a single 9 volt battery. It produces a symmetrical bipolar pulse with a factory-set pulse-width of 600 microseconds and a rate of 1 pulse/second. The transformer-coupled outputs, which are equivalent to the both the BioTENS and the EMPI Model 989, apply 0.0 milliamps of net dc current to the patient. In the burst mode, a fixed train of 8 pulses with a repetition rate of 800 Hz is output once/second. The nominal pulse amplitude is controlled separately for each channel and ranges from 0.0 ma to a maximum of 40 milliamps peak. The 2 channels are isolated from each other and their output pulses are staggered in time to prevent any current from flowing between channels, which results in zero crosstalk. Each channel also includes a balance control that adjusts the amplitudes of the positive and negative half waves differentially. The balance is used to equalize the responses at each electrode site.
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K Number
K003176Device Name
BIOEMG II AND BIOJVA
Manufacturer
BIO-RESEARCH ASSOCIATES, INC.
Date Cleared
2001-01-04
(85 days)
Product Code
KZM
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
BIO-RESEARCH ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991756Device Name
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
Manufacturer
BIO-RESEARCH ASSOCIATES, INC.
Date Cleared
1999-12-10
(200 days)
Product Code
DQD, DOD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
BIO-RESEARCH ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3 Channel Knee Electronic Amplified Stethoscope is intended for use by a physician as a noninvasive tool to amplify and record distinct sounds (vibrations) within the three compartments (medial, lateral, and patellar) of the knee joint.
Device Description
The device is intended for use by a physician as a noninvasive tool to amplify and record distinct sounds (vibrations) within the three compartments (medial, lateral, and patellar) of the knee joint.
The 3 Channel Knee Stethoscope System consists of three transducers, or sensors, to pick up the vibrations (sound) from three locations on the knee. The transducers are plugged into an amplifier box that is connected to a standard personal computer installed with Windows 3.1, or later version. A goniometer attachment is also plugged into the amplifier box. The system generates a metronome arrow that moves on the computer monitor screen (3 seconds per flex/extend cycle). The patient watches the arrow to pace the speed and direction of knee flexion and extension, while staying "in sync" with the metronome to maintain a 3 second cycle. Motion and sound vibrations are amplified, recorded in graph form, and stored in a patient database.
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K Number
K981563Device Name
BIOPAK MEASUREMENT SYSTEM
Manufacturer
BIO-RESEARCH ASSOCIATES, INC.
Date Cleared
1998-09-15
(137 days)
Product Code
KZM, NFQ, NFS
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
BIO-RESEARCH ASSOCIATES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for Use:
At the present time, comparisons between patients of electromyograms, sonograms and / or jaw traces should not be made,
Sufficient normative data have not been collected to support such population-based measurements as "frean electromyographic clench," "standard deviation (Jaw Tracking) of freeway space," "integral (sonograph) of sound intensity" "average jaw tracing of chewing," etc., for non diseased individuals as well as for patients having various disease entitles that are now lumped within the terminology known as "TemporomandIbular Disorders and Associated Orofacial Pain (TMD/MPD)."
Jaw Tracking
- To track mandibular movement and position
- To aid in the diagnosis of TMJ / MPD syndrome, muscle tension and bruxing [instability of occlusion]
- To identify mandibular rest position and to identify interocclusal distance and freeway space
- To monitor the position of the jaw in three dimensions
- To represent the spatial position of the mandibular incisal edge relative to the skull
- To provide Baseline measurements for future reference
Electromyography
- To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric
- To clinically monitor up to eight different muscles as an aid in diagnosis and treatment evaluation by recording the electrical activity of the muscles of the stomatognathic system.
- To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest
- To measure relative (intra-patient) levels of activity of several muscles during a functional act
- To provide Baseline measurements for future reference
Sonography, joint vibration (sound) recording
- To record and display sounds / vibrations from the temporomandibular joint
- To aid the clinician in his analysis of a joint sound / vibration by allowing him to see the waveform in various standard plots
- To aid the clinician in companing a parient's current standard plots to previous recordings before, during and after treatment
- To provide numerical values that can be used to quantify the physical characteristics of the sounds / vibrations allowing intra-bationt commissions (only) by the clinician
- To provide Baseline measurements for future reference
Device Description
Not Found
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