HEALTH PIXEL SRL

Address:VIA GIACOMO LEOPARDI, 7,Milano,IT

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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

Exerciser, Powered (BXB) (1) System, Isokinetic Testing And Evaluation (IKK) (1)

Premarket Exempt

Yes

Clear

Heaxel - 08054329990001 Catalog Number :

Device Description : Robotic system for neurorehabilitation and rehabilitation of the upper limbs and Robotic system for neurorehabilitation and rehabilitation of the upper limbs and shoulders of patients with neuromotor disabilities.

Device Class : 1

Duns Number: 439706071

Premarket Exempt : Yes

Product Code : IKK, BXB

Prescription Use : Yes

Device Count : 1

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