FDA.reportPublic FDA data

TEETHAN

Primary DI
B179THN2
Brand
TEETHAN
Company
BTS SPA
Model
2.0
Catalog number
BTSEMB1BM
Device description
Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter Toclinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity ofmuscles of the stomatognathic system To measure relative (intra-patient) levels of activity of 2 muscles during a functional act
Published
2017-09-26
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
KZMDevice, Muscle Monitoring

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161716000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161716000TEETHAN 2.0Bts S.P.A.2016-12-21KZM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B179THN1PackageHIBCC1In Commercial Distribution
B179THN2PrimaryHIBCC0

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
DM exempt
true
Combination product
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
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
B179TMJ1TMJOINT1.0BTSEMB1BM2017-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003499900BioEMGBio-Research Associates, Inc.KZM2023-06-22
00860003499948BioPAKBio-Research Associates, Inc.KZM2023-06-22
00860003499955M-ScanBio-Research Associates, Inc.KZM2023-06-22
00860003499962M-ScanBio-Research Associates, Inc.KZM2023-06-22
15694311111665Noxturnal US APPNox Medical ehf.KZM2021-10-18
15694311111610Nox A1® EEG 5 Lead Gold Electrode CableNox Medical ehf.KZM2021-09-07
15694311111627Nox A1® EEG Head Cable Nox Medical ehf.KZM2021-09-07
15694311111566Nox A1s RecorderNox Medical ehf.KZM2021-07-10
15694311111580Nox A1s SystemNox Medical ehf.KZM2021-07-10
15694311111597Nox C1s KitNox Medical ehf.KZM2021-07-10
15694311110682Nox A1 Starter Sensor Kit, AdultNox Medical ehf.KZM2021-02-03
15694311110699Nox A1 Starter Sensor Kit, PediatricNox Medical ehf.KZM2021-02-03
15694311111498Nox C1 Access PointNox Medical ehf.KZM2021-02-03
15694311111504Nox C1 KitNox Medical ehf.KZM2021-02-03
00860001651911HindexRVHHS SYSTEMS, INC.KZM2021-01-20
15694311110095Nox A1 Carry CaseNox Medical ehf.KZM2020-04-27
15694311110453Nox A1 EEG 5 Lead Gold Electrode CableNox Medical ehf.KZM2020-04-27
15694311110521Nox A1 EEG Head CableNox Medical ehf.KZM2020-04-27
15694311110019Noxturnal APPNox Medical ehf.KZM2020-02-24
15694311110590Nox C1 Access PointNox Medical ehf.KZM2020-02-24
15694311110903Nox A1 RecorderNox Medical ehf.KZM2020-02-24
15694311111146Nox C1 KitNox Medical ehf.KZM2020-02-24
15694311111368Noxturnal PSG CDNox Medical ehf.KZM2020-02-24
15694311111375Nox A1 SystemNox Medical ehf.KZM2020-02-24
00860001651904HindexRVHHS SYSTEMS, INC.KZM2019-04-26
B179THN1TEETHANBTS SPAKZM2017-09-26
D792N9200A0MES 9000 Dynamic EMGMYOTRONICS NOROMED, INCKZM2017-02-11
D79209750K7 Evaluation System-ESGMYOTRONICS NOROMED, INCKZM2016-09-19
D79209930K7 Evaluation System-EMGMYOTRONICS NOROMED, INCKZM2016-09-19
D792N9000M0MES 9000 Musculoskeletal System MYOTRONICS NOROMED, INCKZM2016-09-19