SafeGait 360 Balance and Mobility Trainer

GUDID 00860012112814

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.

DIH TECHNOLOGY INC.

Gait rehabilitation frame, electric

• Primary Device ID: 00860012112814
• NIH Device Record Key: e321d92c-5285-4578-a76f-5d3ca85fbdf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeGait 360 Balance and Mobility Trainer
• Version Model Number: SG360
• Company DUNS: 197159846
• Company Name: DIH TECHNOLOGY INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012112814 [Primary]

FDA Product Code

• BXB: Exerciser, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-17
• Device Publish Date: 2024-06-08

Devices Manufactured by DIH TECHNOLOGY INC.

• 00860012112814 - SafeGait 360 Balance and Mobility Trainer: 2024-06-17SafeGait 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.
• 00860012112814 - SafeGait 360 Balance and Mobility Trainer: 2024-06-17 SafeGait 360 system (Model SG360) is a body weight support system designed to assist a patient with a walking/balance disability
• 00860012112821 - SafeGait Active Dynamic Mobility Trainer: 2024-06-17 SafeGait Active S1000 system (Model SGAS1000) is designed to assist a patient with some impediments in walking/balance to exerci
• 00860012112838 - SafeGait Active 360 Dynamic Mobility Trainer: 2024-06-17 SafeGait Active 360 system (Model SGA360) is designed to assist a patient with walking/balance impediments to exercise and/or re