REWALK ROBOTICS LTD

Address:3 Hatnufa St. (6th Floor),Upper Yokneam Northern,IL

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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

Powered Exoskeleton (PHL) (4)

Premarket Exempt

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ReStore - 00860001744507 Catalog Number :

Device Description : The device is a lightweight, wearable, battery-powered soft orthotic exosuit int The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.

Device Class : 2

Duns Number: 533320867

Premarket Exempt : No

Product Code : PHL

Prescription Use : Yes

Device Count : 1

ReWalk(TM) Personal 6.0 - 00861803000303 Catalog Number :

Device Description : Powered Exoskeleton - community use

Device Class : 2

Duns Number: 533320867

Premarket Exempt : No

Product Code : PHL

Prescription Use : Yes

Device Count : 1

ReWalk(TM) Personal - 00861803000310 Catalog Number :

Device Description : Powered exoskeleton - community use

Device Class : 2

Duns Number: 533320867

Premarket Exempt : No

Product Code : PHL

Prescription Use : Yes

Device Count : 1

ReWalk(TM) Rehabilitaiton - 00861803000327 Catalog Number :

Device Description : Powered Exoskeleton - rehabilitation institution use

Device Class : 2

Duns Number: 533320867

Premarket Exempt : No

Product Code : PHL

Prescription Use : Yes

Device Count : 1

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