TeleMyo

GUDID 00816271020148

Telemyo Mini Receiver

Noraxon U.S.A., Inc.

Biofeedback system Biofeedback system Biofeedback system Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set Kinesiology/electromyographic sensor set

• Primary Device ID: 00816271020148
• NIH Device Record Key: b49b9a80-17e5-4446-82f2-2d07e6d343bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TeleMyo
• Version Model Number: 585
• Company DUNS: 611243809
• Company Name: Noraxon U.S.A., Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com
• Phone: 4804433413
• Email: support@noraxon.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816271020148 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-08

On-Brand Devices [TeleMyo]

• 00816271020155: Telemyo DTS Desktop Receiver (W/O Analog Out)
• 00816271020148: Telemyo Mini Receiver
• 00816271020131: Telemyo Clinical DTS Receiver
• 00816271020124: Telemyo DTS Desktop Receiver
• 00816271020117: Telemyo DTS Belt Receiver
• 00816271020100: Telemyo Research DTS EMG Lossless
• 00816271020094: Telemyo Clinical DTS EMG
• 00816271020087: Telemyo DTS EMG
• 00816271020063: TeleMyo Sensor Charger
• 00816271020056: Telemyo PC-Interface
• 00816271020049: Telemyo 2400T G2
• 00816271020292: Telemyo Research DTS EMG
• 00816271020858: Telemyo 2400 G2 Transmitter
• 00816271020070: Telemyo 2400R G2 Analog Output Receiver