MyoVision Wirefree System

GUDID 00864021000377

Solo Vision Hub with FlexVision FlexLite Inclinometers

PRECISION BIOMETRICS INC

Multiple physiological signal amplifier

• Primary Device ID: 00864021000377
• NIH Device Record Key: 0607a5aa-9b7e-44a2-a482-c7337feab423
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoVision Wirefree System
• Version Model Number: D11-D5 FlexLite
• Company DUNS: 362997926
• Company Name: PRECISION BIOMETRICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864021000377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123399

FDA Product Code

• KQX: Goniometer, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-15

On-Brand Devices [MyoVision Wirefree System]

• 00864021000391: Solo Vision Hub with ScanVision Static sEMG Scaners
• 00864021000384: Solo Vision Hub with DynaVision Dynamic sEMG
• 00864021000377: Solo Vision Hub with FlexVision FlexLite Inclinometers
• 00864021000360: Solo Vision Hub with FlexVision Inclinometers
• 00853818007354: PhysioMonitor Hub with FlexVision Inclinomters DynaVision Dynamic sEMG and ScanVision Lite Stati
• 00853818007347: Solo Vision Hub with ScanVision Lite Static sEMG Scaner
• 00853818007040: PhysioMonitor Hub with DynaVision Dynamic sEMG and ScanVision Static sEMG Scaners
• 00853818007033: PhysioMonitor Hub with FlexVision FlexLite Inclinomters and ScanVision Static sEMG Scaners
• 00853818007026: PhysioMonitor Hub with Flexvision Inclinomters and ScanVision Static sEMG Scaners
• 00853818007019: PhysioMonitor Hub with Flexvision Inclinomters DynaVision Dynamic sEMG and ScanVision Static sEM
• 00853818007002: PhysioMonitor Hub with Flexvision Inclinomters and DynaVision Dynamic sEMG
• 00853818007415: VisionHub with FlexVision Inclinometers and DynaVision Dynamic sEMG
• 00853818007460: VisionHUB with DynaVision Dynamic sEMG