DEVICE: Optimal-G (07290017844312)

Device Identifier (DI) Information

Optimal-G
A
In Commercial Distribution
OG01-0000-01
MOTORIKA MEDICAL (ISRAEL) LTD
07290017844312
GS1

1
534078621 *Terms of Use
The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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

GMDN Preferred Term Name GMDN Definition
Gait rehabilitation system harness A lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait.
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FDA Product Code

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Product Code Product Code Name
BXB Exerciser, Powered
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FDA Premarket Submission

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Sterilization

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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
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Device Record Status

a87c468d-062a-4fd7-965e-21257bdca2c8
July 08, 2019
1
June 30, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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