BioJVA

Primary DI
00860003499924
Brand
BioJVA
Company
Bio-Research Associates, Inc.
Model
Amplifier 1608FS
Device description
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.
Published
2023-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFQDevice, Dental Sonography, For Monitoring Jaw Sounds

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFQDevice, Dental Sonography, For Monitoring Jaw SoundsDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905657000SONOPAK/QS, SONOPAKBioresearch1991-05-15NFQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003499924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003499924008600034999248600034999240860003499924

GMDN Terms#

Term, Definition table
TermDefinition
Jaw physiology evaluation systemAn assembly of mains electricity (AC-powered) devices designed to record parameters for mandibular and muscles of mastication function, primarily to aid in the diagnosis and treatment of temperomandibular joint (TMJ) and myofascial pain dysfunction (MPD) disorders, and for orthodontic, denture, and reconstruction patient evaluation. It typically uses surface electromyography to evaluate muscle groups at rest or in function; sonography to detect sounds/vibrations from the TMJ joint and/or other computer-based system to non-invasively track the mandible in function or identify its position in space relative to the skull.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4143577525info@bioresearchinc.com

Regulatory Flags#

DUNS number
063501373
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009598201Taylor IndustriesLong Term Monitoring Electrode2023-08-17
00860003499900BioEMGIII NRG V22023-06-22
00860003499917JT-3DNR 16 Channel2023-06-22
00860003499931BioJVAHeadset2023-06-22
00860003499948BioPAK92023-06-22
00860003499955M-ScanRest2023-06-22
00860003499962M-ScanClench2023-06-22
00860003499979QuadraTENSUnit2023-06-22
00860009598218BioJVAAmplifier USB-2312023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003499931BioJVABio-Research Associates, Inc.NFQ2023-06-22
00860009598218BioJVABio-Research Associates, Inc.NFQ2023-06-22
D79209750K7 Evaluation System-ESGMYOTRONICS NOROMED, INCNFQ2016-09-19
D79209830K7 ESG-2 ElectrosonographMYOTRONICS NOROMED, INCNFQ2016-08-18