MyoVision DynaVision Dynamic sEMG D6

GUDID 00864021000346

PRECISION BIOMETRICS INC

Multiple physiological signal amplifier
Primary Device ID00864021000346
NIH Device Record Key9d57d8ab-62fe-496e-8686-d0763f7b4f79
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyoVision DynaVision Dynamic sEMG
Version Model NumberD6
Catalog NumberD6
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS100864021000346 [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

Devices Manufactured by PRECISION BIOMETRICS INC

10853818007504 - USB C Adapter2024-09-11 PB-210-1, USB C to A adapter
00853818007491 - USB A to C Cable2024-09-11 PB-209, USB A to C cable
00853818007507 - USB C to C Cable2024-09-11 PB-210, USB C to C cable
00853818007477 - MyoVision Software2022-11-18 Software
00853818007460 - MyoVision Wirefree System2021-05-25 VisionHUB with DynaVision Dynamic sEMG
00853818007422 - SERIES-5 MyoVision Full System2021-03-08 VisionHub with FlexVision Inclinometers, DynaVision Dynamic sEMG and ScanVision Static sEMG Scanner
00853818007439 - SERIES-5 MyoVision ScanVision2021-03-08 SERIES-5 VisionHUB with ScanVision Static sEMG Scanner
00853818007446 - SERIES-5 MyoVision ScanVision2021-03-08 SERIES-5 VisionHUB with ScanVision Static sEMG Scanners

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