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 Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph Electromyograph

• Primary Device ID: B179THN1
• NIH Device Record Key: a0127a34-f916-48d0-a5ba-e331b0b93b91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEETHAN
• Version Model Number: 2.0
• Catalog Number: BTSEMB1BM
• Company DUNS: 428484518
• Company Name: BTS SPA
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B179THN1 [Package]; Contains: B179THN2; Package: [1 Units]; In Commercial Distribution
HIBCC	B179THN2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161716

FDA Product Code

• KZM: Device, Muscle Monitoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-26

Devices Manufactured by BTS SPA

• B179SDXEVO1 - SMART: 2023-09-14 SMART is a System for motion analysis, intended for the recording and analysis of human movement patterns in the. fields of reha
• B179BAIO11 - baiobit: 2020-12-22 BAIOBIT is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tr
• B179SDX - SMART: 2018-07-06 SMART is a System for motion analysis, intended for the recording and analysis of human movement patterns in the. fields of reha
• B179THN1 - TEETHAN: 2018-07-06Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2
• B179THN1 - TEETHAN: 2018-07-06 Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter T
• B179FE31 - FREEEMG: 2018-03-29 BTS FREEEMG 300 is a wireless surface electromyograph, which makes the selection of muscles, the setting of duration and frequen
• B179FR11 - FREEEMG: 2018-03-29 BTS FREEEMG 1000 is a wireless surface electromyograph for the acquisition and transmission of EMG signals and for the assessmen
• B179GSN2 - G-SENSOR: 2018-03-29 BTS G-SENSOR 2 is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, a
• B179OMN - OMNIsEMG: 2018-03-29 BTS OMNIsEMG is an instrument for the electromyographic surface analysis.