Professional Suite PS100

GUDID B7580000PS100

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 IDB7580000PS100
NIH Device Record Key9945b095-c96d-491e-8bbc-cf131780c6aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameProfessional Suite
Version Model Number0000PS100
Catalog NumberPS100
Company DUNS757139956
Company NameDORSAVI LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com
Phone+611800367728
Emailsupport@dorsavi.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB7580000PS100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQXGoniometer, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-30
Device Publish Date2019-09-26

On-Brand Devices [Professional Suite]

B7580000PS100000000000Professional Suite is a wireless medical device that measures, records, and reports movements an
B7580000PS100Professional Suite is a wireless medical device that measures, records, and reports movements an

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