MyoVision Wirefree System D2-D5-D6

GUDID 00853818007415

VisionHub with FlexVision Inclinometers and DynaVision Dynamic sEMG

PRECISION BIOMETRICS INC

Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier
Primary Device ID00853818007415
NIH Device Record Keya4e9d084-70d8-46cb-869c-7b41b1a26268
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyoVision Wirefree System
Version Model NumberD2-D5-D6
Catalog NumberD2-D5-D6
Company DUNS362997926
Company NamePRECISION BIOMETRICS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com
Phone800-969-6961
Emailadmin@myovision.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]
GS100853818007415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered
KQXGoniometer, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

On-Brand Devices [MyoVision Wirefree System]

00864021000391Solo Vision Hub with ScanVision Static sEMG Scaners
00864021000384Solo Vision Hub with DynaVision Dynamic sEMG
00864021000377Solo Vision Hub with FlexVision FlexLite Inclinometers
00864021000360Solo Vision Hub with FlexVision Inclinometers
00853818007354PhysioMonitor Hub with FlexVision Inclinomters DynaVision Dynamic sEMG and ScanVision Lite Stati
00853818007347Solo Vision Hub with ScanVision Lite Static sEMG Scaner
00853818007040PhysioMonitor Hub with DynaVision Dynamic sEMG and ScanVision Static sEMG Scaners
00853818007033PhysioMonitor Hub with FlexVision FlexLite Inclinomters and ScanVision Static sEMG Scaners
00853818007026PhysioMonitor Hub with Flexvision Inclinomters and ScanVision Static sEMG Scaners
00853818007019PhysioMonitor Hub with Flexvision Inclinomters DynaVision Dynamic sEMG and ScanVision Static sEM
00853818007002PhysioMonitor Hub with Flexvision Inclinomters and DynaVision Dynamic sEMG
00853818007415VisionHub with FlexVision Inclinometers and DynaVision Dynamic sEMG

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