KINVENT HELLAS

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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

Dynamometer, Ac-Powered (LBB) (4) Platform, Force-Measuring (KHX) (2) Goniometer, Ac-Powered (KQX) (1)

Premarket Exempt

Yes

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KINVENT - 03770011995004 Catalog Number :

Device Description : Link is a traction dynamometer for the measurement of isometric strength and bio Link is a traction dynamometer for the measurement of isometric strength and biofeedback training. Link enables independent measurements. It can be fixed on a physiotherapists table, on the espalier or on pulley machines.

Device Class : 2

Duns Number: 524664525

Premarket Exempt : Yes

Product Code : LBB

Prescription Use : No

Device Count : 1

KINVENT - 03770011995097 Catalog Number :

Device Description : Deltas are two independent force platforms for rehabilitating balance and assess Deltas are two independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength.

Device Class : 1

Duns Number: 524664525

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

KINVENT - 03770011995103 Catalog Number :

Device Description : Muscle Controller is a hand held dynamometer used for the evaluation of muscles Muscle Controller is a hand held dynamometer used for the evaluation of muscles strength. You can assess isometric strength by the way of the peak force as well as of the average force for a specific muscle or muscle groups.The Muscle Controller allows to quantitatively measure the muscle strength and the deficit percentage caused by injury compared to the strength of the healthy side

Device Class : 2

Duns Number: 524664525

Premarket Exempt : Yes

Product Code : LBB

Prescription Use : No

Device Count : 1

KINVENT - 03770011995226 Catalog Number :

Device Description : Plates are two independent force platforms for rehabilitating balance and assess Plates are two independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength.

Device Class : 1

Duns Number: 524664525

Premarket Exempt : Yes

Product Code : KHX

Prescription Use : No

Device Count : 1

KINVENT - 03770011995332 Catalog Number :

Device Description : Grip is used for the evaluation of hand grip strength. You can assess isometric Grip is used for the evaluation of hand grip strength. You can assess isometric strength by the way of the peak force as well as of the average force. The Grip dynamometer allows to quantitatively measure the grip weakness caused by injury compared to the strength of the healthy hand

Device Class : 2

Duns Number: 524664525

Premarket Exempt : Yes

Product Code : LBB

Prescription Use : No

Device Count : 1

KINVENT - 03770011995448 Catalog Number :

Device Description : Bubble is a pneumatic sensor allowing you to work your strength with convenient Bubble is a pneumatic sensor allowing you to work your strength with convenient inflatable tools.

Device Class :

Duns Number: 524664525

Premarket Exempt : Yes

Product Code : LBB

Prescription Use : No

Device Count : 1

KINVENT - 03770011995554 Catalog Number :

Device Description : Sens is an inertial sensor to measure the range of motion and to compare the sym Sens is an inertial sensor to measure the range of motion and to compare the symmetry between the injured limb’s amplitude andthe healthy limb.

Device Class : 1

Duns Number: 524664525

Premarket Exempt : Yes

Product Code : KQX

Prescription Use : No

Device Count : 1

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