SERIES-5 MyoVision FlexVision System D2-D5-D5

GUDID 00853818007453

SERIES-5 VisionHUB with FlexVision Inclinometers

PRECISION BIOMETRICS INC

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

• 10853818007504 - USB C Adapter: 2024-09-11 PB-210-1, USB C to A adapter
• 00853818007491 - USB A to C Cable: 2024-09-11 PB-209, USB A to C cable
• 00853818007507 - USB C to C Cable: 2024-09-11 PB-210, USB C to C cable
• 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