ViMove+ VMPLU

GUDID B758000VMPLU0

ViMove+ is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

DORSAVI LTD

Psychophysiological biofeedback system

• Primary Device ID: B758000VMPLU0
• NIH Device Record Key: 83133e4a-9c17-4b4d-be72-5e21ed8b734e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViMove+
• Version Model Number: 000VMPLU0
• Catalog Number: VMPLU
• Company DUNS: 757139956
• Company Name: DORSAVI LTD
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com
• Phone: +611800367728
• Email: support@dorsavi.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B758000VMPLU0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163150

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: 2023-09-07
• Device Publish Date: 2023-08-30

Devices Manufactured by DORSAVI LTD

• B75800RDA445 - dorsaVi - V6 Overwrap Adhesives: 2023-09-07 Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.
• B75800RDA865 - dorsaVi - V6 EMG DAP: 2023-09-07 Single use disposable application pad adhesive for use with dorsaVi Version 6 EMG Sensors.
• B75800RDA866 - dorsaVi - V6 Low Back AMI DAP: 2023-09-07 Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.
• B758000VMPLU0 - ViMove+: 2023-09-07ViMove+ is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
• B758000VMPLU0 - ViMove+: 2023-09-07 ViMove+ is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumba
• B758000035630 - 30 Minute Disposable Application Pad: 2023-08-30 Single use disposable application pad adhesive for use with dorsaVi Version 5 MDM Sensors for Movement Suite Kits.
• B7580000PS100 - Professional Suite: 2023-08-30 Professional Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lower b
• B7580000VMV50 - Movement Suite / V5 Sensor Kit: 2023-08-30 Movement Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back
• B758000RDA482 - dorsaVi: 2023-08-30 Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.