DEVICE: EksoNR (B168EKSONR0)

Device Identifier (DI) Information

EksoNR
EKSONR
In Commercial Distribution
EKSONR
EKSO BIONICS, INC.
B168EKSONR0
HIBCC

1
190152921 *Terms of Use
EKSO BIONICS SYSTEM, Ekso NR
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58943 Programmable ambulation exoskeleton, clinical
A battery-powered, pre-programmed, lower-limb orthosis system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by manipulating the legs through a normal walking pattern during ambulation. The system includes an exoskeleton structure made of metal with electric motors, mechanical actuators, and sensors for feedback; it is typically strapped to the legs over clothing. It is intended for multiple-patient use, in a controlled clinical setting (e.g., gait lab, rehabilitation centre) under healthcare professional supervision.
Active false
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FDA Product Code

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Product Code Product Code Name
PHL Powered Exoskeleton
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K200574 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

bb2be74d-eb3b-4b50-a82f-7a5247bfaa81
March 11, 2022
1
March 03, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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No
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Customer Contact

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No Customer Contact currently defined
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