MyoVision Wirefree System D3-D6-D7

GUDID 00853818007040

PhysioMonitor Hub with DynaVision Dynamic sEMG and ScanVision Static sEMG Scaners

PRECISION BIOMETRICS INC

Multiple physiological signal amplifier
Primary Device ID00853818007040
NIH Device Record Key166072c8-c144-44af-90ca-480480aa5a8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyoVision Wirefree System
Version Model NumberD3-D6-D7
Catalog NumberD3-D6-D7
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100853818007040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQXGoniometer, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-15

On-Brand Devices [MyoVision Wirefree System]

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00853818007347Solo Vision Hub with ScanVision Lite Static sEMG Scaner
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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
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00853818007415VisionHub with FlexVision Inclinometers and DynaVision Dynamic sEMG
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