ReStore

GUDID 00860001744507

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.

REWALK ROBOTICS LTD

Programmable ambulation exoskeleton, clinical

• Primary Device ID: 00860001744507
• NIH Device Record Key: 58b3baf7-e553-490e-a338-ec02cc3dfb42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReStore
• Version Model Number: 50-40-0001
• Company DUNS: 533320867
• Company Name: REWALK ROBOTICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001744507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190337

FDA Product Code

• PHL: Powered Exoskeleton

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-24
• Device Publish Date: 2019-10-16

Devices Manufactured by REWALK ROBOTICS LTD

• 00860001744507 - ReStore: 2019-10-24The 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.
• 00860001744507 - ReStore: 2019-10-24 The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions
• 00861803000303 - ReWalk(TM) Personal 6.0: 2018-07-06 Powered Exoskeleton - community use
• 00861803000327 - ReWalk(TM) Rehabilitaiton: 2018-07-06 Powered Exoskeleton - rehabilitation institution use
• 00861803000310 - ReWalk(TM) Personal: 2018-03-29 Powered exoskeleton - community use