TEETHAN BTSEMB1BM

GUDID B179THN1

Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2

BTS SPA

Electromyograph
Primary Device IDB179THN1
NIH Device Record Keya0127a34-f916-48d0-a5ba-e331b0b93b91
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEETHAN
Version Model Number2.0
Catalog NumberBTSEMB1BM
Company DUNS428484518
Company NameBTS SPA
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB179THN1 [Package]
Contains: B179THN2
Package: [1 Units]
In Commercial Distribution
HIBCCB179THN2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KZMDevice, Muscle Monitoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-26

Devices Manufactured by BTS SPA

B179SEVBUN050 - SMART2025-01-06 SMART-DX EVO TVC camera component of SMART that is a System for motion analysis, intended for the recording and analysis of huma
B179SEVBUN090 - SMART2025-01-06 SMART-DX EVO TVC camera component of SMART that is a System for motion analysis, intended for the recording and analysis of huma
B179SEVBUN260 - SMART2025-01-06 SMART-DX EVO TVC camera component of SMART that is a System for motion analysis, intended for the recording and analysis of huma
B179SDXEVO1 - SMART2023-09-14 SMART is a System for motion analysis, intended for the recording and analysis of human movement patterns in the. fields of reha
B179BAIO11 - baiobit2020-12-22 BAIOBIT is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tr
B179SDX - SMART2018-07-06 SMART is a System for motion analysis, intended for the recording and analysis of human movement patterns in the. fields of reha
B179THN1 - TEETHAN2018-07-06Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2
B179THN1 - TEETHAN2018-07-06 Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter T
B179FE31 - FREEEMG2018-03-29 BTS FREEEMG 300 is a wireless surface electromyograph, which makes the selection of muscles, the setting of duration and frequen
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.