TeleMyo
GUDID 00816271020148
Telemyo Mini Receiver
Noraxon U.S.A., Inc.
Biofeedback system| 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 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| support@noraxon.com | |
| Phone | 4804433413 |
| 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 |
Trademark Results [TeleMyo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TELEMYO 78633610 3331041 Dead/Cancelled |
Noraxon USA, Inc. 2005-05-19 |
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