BioEMG

Primary DI
00860003499900
Brand
BioEMG
Company
Bio-Research Associates, Inc.
Model
III NRG V2
Device description
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.
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
KZMDevice, Muscle Monitoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZMDevice, Muscle MonitoringPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082927000BIOEMG IIIBio-Research Associates, Inc.2009-02-06KZM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003499900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003499900008600034999008600034999000860003499900

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
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