DORSAVI LTD

Address:3 / 11-13 Milgate Street,Oakleigh South Victoria,AU

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Biofeedback (HCC) (4) Electromyograph, Diagnostic (IKN) (2) Goniometer, Ac-Powered (KQX) (2)

Premarket Exempt

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Professional Suite - B7580000PS100000000000 Catalog Number : PS100

Device Description : Professional Suite is a wireless medical device that measures, records, and repo Professional Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lowerback / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

Device Class : 1

Duns Number: 757139956

Premarket Exempt : No

Product Code : KQX, HCC, IKN

Prescription Use : Yes

Device Count : 1

dorsaVi - B7580000RDA482000000000 Catalog Number : RS-A482

Device Description : Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.

Device Class : 2

Duns Number: 757139956

Premarket Exempt : No

Product Code : HCC

Prescription Use : No

Device Count : 1

Movement Suite / V5 Sensor Kit - B7580000VMV50000000000 Catalog Number : VMV50

Device Description : Movement Suite is a wireless medical device that measures, records, and reports Movement Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lowerback / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

Device Class : 1

Duns Number: 757139956

Premarket Exempt : No

Product Code : KQX, HCC, IKN

Prescription Use : Yes

Device Count : 1

30 Minute Disposable Application Pad - B7580356300000000000001 Catalog Number : 0356-30

Device Description : Single use disposable application pad adhesive for use with dorsaVi Version 5 MD Single use disposable application pad adhesive for use with dorsaVi Version 5 MDM Sensors for Movement Suite Kits.

Device Class :

Duns Number: 757139956

Premarket Exempt : No

Product Code : HCC

Prescription Use : No

Device Count : 50

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