FDA.reportPublic FDA data

BIO-RESEARCH ASSOCIATES, INC.

Matched from indexed company URL: Bio-Research Associates, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21835522183552BIO-RESEARCH ASSOCIATES, INC.1Y2026-01-0112308 Corporate Pkwy Ste 450 Mequon WI US 53092

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860003499900BioEMG - Indications for use: 8 channel EMG Amplifier1. 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 amplifier1. To record and display sounds/vibrations from the temporomandibular joints.2. To aid the clinician in their analysis of a joint sound/vibration by allowing them to see the waveform in various standard plots.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.4143577525info@bioresearchinc.com
00860003499917JT-3D - The Jaw Tracker-3D is a non-invasive, non-painful test that records incisor-point movements in three dimensions. A small magnet, attached to the labial surfaces of the mandibular incisors, is tracked to produce vertical, anteroposterior, and lateral movement data. Jaw tracking can assist in designing optimal chewing patterns as well as detecting abnormal functions which can aid in more accurate diagnosis. It also assists in recording accurate, reproducible “bite registrations.”4143577525info@bioresearchinc.com
00860003499924BioJVA - Indications for use: 2 channel JVA amplifier1. To record and display sounds/vibrations from the temporomandibular joints.2. To aid the clinician in their analysis of a joint sound/vibration by allowing them to see the waveform in various standard plots.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.4143577525info@bioresearchinc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
358401571498853K981563BIOPAK MEASUREMENT SYSTEMKZM1998-09-15
358401326019419K972140A1 ACOUSTIC RHINOMETERBXQ1998-09-30
358401987992251K952218JT-3 ELECTROGNATHOGRAPHNFS1995-09-21
358401733125949K905657SONOPAK/QS, SONOPAKNFQ1991-05-15
358401616879439K902120MERCURY RHINOMANOMETERBXQ1990-08-06
358401215519536K844618BIO-TENSGZJ1985-08-21
358401299812969K130158M-SCANKZM2013-07-25
358401883217157K111901ASA 'MPHI FAMILY DIODE LASERILY2011-11-09
358401817751091K082927BIOEMG IIIKZM2009-02-06
358401594762099K061799QUADRATENS, MODEL QT-42GZJ2006-08-28
358401655823541K003176BIOEMG II AND BIOJVAKZM2001-01-04
358401639388870
358401669821461

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KZM42013-07-25
GZJ22006-08-28
BXQ21998-09-30
ILY12011-11-09
NFS11995-09-21
NFQ11991-05-15

PMN#

M-SCAN

2013-07-25

BIO-RESEARCH ASSOCIATES, INC.

BIO-TENS

1985-08-21

BIO-RESEARCH ASSOCIATES, INC.

GUDID#

BioEMG - Indications for use: 8 channel EMG Amplifier1. 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 amplifier1. To record and display sounds/vibrations from the temporomandibular joints.2. To aid the clinician in their analysis of a joint sound/vibration by allowing them to see the waveform in various standard plots.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.

Bio-Research Associates, Inc.

2023-06-22

JT-3D - The Jaw Tracker-3D is a non-invasive, non-painful test that records incisor-point movements in three dimensions. A small magnet, attached to the labial surfaces of the mandibular incisors, is tracked to produce vertical, anteroposterior, and lateral movement data. Jaw tracking can assist in designing optimal chewing patterns as well as detecting abnormal functions which can aid in more accurate diagnosis. It also assists in recording accurate, reproducible “bite registrations.”

Bio-Research Associates, Inc.

2023-06-22

BioJVA - Indications for use: 2 channel JVA amplifier1. To record and display sounds/vibrations from the temporomandibular joints.2. To aid the clinician in their analysis of a joint sound/vibration by allowing them to see the waveform in various standard plots.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.

Bio-Research Associates, Inc.

2023-06-22

BioJVA - Indications for use: 2 channel JVA amplifier1. To record and display sounds/vibrations from the temporomandibular joints.2. To aid the clinician in their analysis of a joint sound/vibration by allowing them to see the waveform in various standard plots.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.

Bio-Research Associates, Inc.

2023-06-22