MyoPad Vault

GUDID 00853818007279

MyoPad Vault (1), QuickScan Pads (2 jars), Low-profile tweezers (1)

PRECISION BIOMETRICS INC

Electrode conductive medium
Primary Device ID00853818007279
NIH Device Record Key55cb0ca4-f46c-4f8c-af03-af62f1faf086
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyoPad Vault
Version Model NumberPB-250
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 Usetrue
Lot Batchfalse
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
GS100853818007279 [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 Number4
Public Version Date2018-10-22
Device Publish Date2016-12-13

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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