DEVICE: Indego (M704501100000)

Device Identifier (DI) Information

Indego
501-100-000
In Commercial Distribution

PARKER-HANNIFIN CORPORATION
M704501100000
HIBCC

1
079799957 *Terms of Use
Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
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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
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.
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FDA Product Code

[?]
Product Code Product Code Name
PHL Powered Exoskeleton
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152416 000
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Sterilization

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

[?]
Storage and Handling
Handling Environment Temperature: between 0 and 31 Degrees Celsius
Handling Environment Humidity: between 45 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 78 and 101 KiloPascal
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 11.6 and 101 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

91f6cd0d-a247-42b8-9fec-e3f175140b80
July 06, 2018
3
September 15, 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
Yes
No CLOSE

Customer Contact

[?]
844-846-3346
support.indego@parker.com
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