Focus

GUDID 04650075330074

2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from

NEUROSOFT, OOO

Electromyograph

• Primary Device ID: 04650075330074
• NIH Device Record Key: dc9c50b2-c803-480c-9d32-fa20e1bb6bad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Focus
• Version Model Number: Focus
• Company DUNS: 643212926
• Company Name: NEUROSOFT, OOO
• Device Count: 1
• DM Exempt: false
• 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: false
• 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

Customer Support Contacts

• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04650075330074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102610

FDA Product Code

• JXE: Device, Nerve Conduction Velocity Measurement

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: 2016-09-22

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• 04650075333952 - CloudTMS for OCD: 2023-12-22 No description.
• 04650075333969 - CloudTMS for OCD: 2023-12-22 No description.
• 04650075332078 - Steadys-Step: 2023-08-22 System is intended for objective gait analysis and biofeedback gait training based on EMG and IMU (Inertial Measurement Unit) da
• 04650075334003 - aTymp: 2023-02-10 The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting