FDA.reportPublic FDA data

TMJOINT

Primary DI
B179TMJ
Brand
TMJOINT
Company
BTS SPA
Model
1.0
Catalog number
BTSEMB1BM
Device description
BTS TMJOINT is a wireless surface electromyograph to measure thedifferential influence of the occlusal function through indices validatedand published in scientific literature
Published
2017-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B179TMJ1PackageHIBCC1In Commercial Distribution
B179TMJPrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ElectromyographAn electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.

Regulatory Flags#

DUNS number
428484518
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B179SEVBUN050SMARTDX EVO5SEVBUN052024-12-27
B179SEVBUN090SMARTDX EVO9SEVBUN092024-12-27
B179SEVBUN260SMARTDX EVO26SEVBUN262024-12-27
B179SEVBUN020SMARTDX EVO2SEVBUN022024-12-20
B179SDXEVO1SMARTDX EVOBTSNET82023-09-06
B179FE3FREEEMG300BTSFE32016-07-06
B179FR1FREEEMG1000BTSEMB1BM2016-07-06
B179THN2TEETHAN2.0BTSEMB1BM2017-09-26
B179OMNOMNIsEMG1.0BTSEMB1BM2017-02-12
B179BAIO1baiobit12020-12-14
B179BAIO11baiobit12020-12-14
B179SDXSMARTDXBTSSDX2017-02-12
B179THN1TEETHAN2.0BTSEMB1BM2017-09-26
B179FE31FREEEMG300BTSFE32016-07-06
B179FR11FREEEMG1000BTSEMB1BM2016-07-06
B179GSN2G-SENSOR2BTSGSN22016-07-06
B179P6KP60006000BTSP6K2017-02-12
B179TMJ1TMJOINT1.0BTSEMB1BM2017-02-12

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Primary DI, Brand, Company table
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04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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