Professional Suite PS100

GUDID B7580000PS100000000000

Professional Suite 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: B7580000PS100000000000
• NIH Device Record Key: 9945b095-c96d-491e-8bbc-cf131780c6aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Professional Suite
• Version Model Number: 0000PS100000000000
• Catalog Number: PS100
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B7580000PS100000000000 [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: 2019-10-04
• Device Publish Date: 2019-09-26

On-Brand Devices [Professional Suite]

• B7580000PS100000000000: Professional Suite is a wireless medical device that measures, records, and reports movements an
• B7580000PS100: Professional Suite is a wireless medical device that measures, records, and reports movements an