DEVICE: SafeGait 360 Balance and Mobility Trainer (00860012112814)

Device Identifier (DI) Information

SafeGait 360 Balance and Mobility Trainer
SG360
In Commercial Distribution

DIH TECHNOLOGY INC.
00860012112814
GS1

1
197159846 *Terms of Use
SafeGait 360 system (Model SG360) is a body weight support system designed to assist a patient with a walking/balance disability to regain mobility via exercise and gait training. SafeGait 360 system tethers patients with a dedicated harness hanging from a powered device running on the overhead aluminum rails to offload the patient’s weight to various levels configurable via a computer or a handheld device. SafeGait 360 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait 360 system shall only be operated by trained clinicians, therapists or DIH staff.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58875 Gait rehabilitation frame, electric
An electrically-powered, body-weight unloading, gait rehabilitation device designed to assist a patient with a walking/balance disability (neurogenic, muscular, or osseous in origin) regain lost motor function, by enabling them to hang in a dedicated harness in a vertical position and exercise (e.g., walk over the ground or moving surface of an elliptical/treadmill, climb stairs, perform sit-to-stand movements). It consists of a ceiling- or wall-mounted beam, or floor-standing frame with a motorized attachment assembly connected to the harness which supports the body weight. It is intended to be used in a clinical setting under professional supervision.
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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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No Sterilization Methods Found
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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
No Device Sizes
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Device Record Status

e321d92c-5285-4578-a76f-5d3ca85fbdf4
June 17, 2024
1
June 08, 2024
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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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