FDA.reportPublic FDA data

TMJOINT

Primary DI
B179TMJ1
Brand
TMJOINT
Company
BTS SPA
Model
1.0
Catalog number
BTSEMB1BM
Device description
BTS TMJOINT is a wireless surface electromyograph to measure the differential influence of the occlusal function through indices validated and publis
Published
2017-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
ElectromyographA mains electricity (AC-powered) device designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle. The electromyograph (EMG) is typically used in clinical diagnosis of muscular disorders to evaluate muscle weakness and to determine if the weakness is related to the muscles themselves or a problem with the nerves that supply the muscles.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428484518
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
B179TMJTMJOINT1.0BTSEMB1BM2017-02-12
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

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