DEVICE: ReWalk(TM) Personal 6.0 (00861803000303)

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Device Identifier (DI) Information

ReWalk(TM) Personal 6.0
50-20-0004

REWALK ROBOTICS LTD
00861803000303
GS1
1
Powered Exoskeleton - community use
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ambulation exoskeleton, home-use A battery-powered, bionic, lower-limb orthosis system intended to enable a patient with a walking disability resulting from spinal cord injury to perform routine ambulatory functions (e.g., stand, walk, ascend and descend stairs); it may also be used to help promote intrinsic motor function. It is typically strapped to the patient over clothing and includes an exoskeleton structure made of metal, with electric motors, mechanical actuators and sensors, an on-board computer, and controls. It is intended for single-patient use, typically outside of a controlled setting following completion of training under professional supervision.
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FDA Product Code

[?]
Product Code Product Code Name
PHL Powered Exoskeleton
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 08, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1 (508) 251-1154
contact@rewalk.com
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