SERIES-5 MyoVision FlexVision System D2-D5-D5

GUDID 00853818007453

SERIES-5 VisionHUB with FlexVision Inclinometers

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

• Primary Device ID: 00853818007453
• NIH Device Record Key: d71c09e8-999d-4408-b3c4-087294c0f868
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SERIES-5 MyoVision FlexVision System
• Version Model Number: D2-D5
• Catalog Number: D2-D5-D5
• 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	00853818007453 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-28

Devices Manufactured by PRECISION BIOMETRICS INC

• 00853818007477 - MyoVision Software: 2022-11-18 Software
• 00853818007460 - MyoVision Wirefree System: 2021-05-25 VisionHUB with DynaVision Dynamic sEMG
• 00853818007422 - SERIES-5 MyoVision Full System: 2021-03-08 VisionHub with FlexVision Inclinometers, DynaVision Dynamic sEMG and ScanVision Static sEMG Scanner
• 00853818007439 - SERIES-5 MyoVision ScanVision: 2021-03-08 SERIES-5 VisionHUB with ScanVision Static sEMG Scanner
• 00853818007446 - SERIES-5 MyoVision ScanVision: 2021-03-08 SERIES-5 VisionHUB with ScanVision Static sEMG Scanners
• 00853818007453 - SERIES-5 MyoVision FlexVision System: 2021-03-08SERIES-5 VisionHUB with FlexVision Inclinometers
• 00853818007453 - SERIES-5 MyoVision FlexVision System: 2021-03-08 SERIES-5 VisionHUB with FlexVision Inclinometers
• 00853818007415 - MyoVision Wirefree System: 2021-01-13 VisionHub with FlexVision Inclinometers and DynaVision Dynamic sEMG
• 00853818007330 - USB Charger: 2020-02-06 USB Wall Charger