SafeGait Active Dynamic Mobility Trainer

GUDID 00860012112821

SafeGait Active S1000 system (Model SGAS1000) is designed to assist a patient with some impediments in walking/balance to exercise and/or to regain normal gait. SafeGait Active S1000 system tethers patients with a dedicated harness hanging from a powered pneumatic braking device on the overhead steel rails moved by pulling force from the patient. SafeGait Active S1000 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait Active S1000 system shall only be operated by trained clinicians, therapists or DIH staff.

DIH TECHNOLOGY INC.

Gait rehabilitation frame, electric

• Primary Device ID: 00860012112821
• NIH Device Record Key: c94d992c-d94c-4a79-858f-dbec3d951c18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeGait Active Dynamic Mobility Trainer
• Version Model Number: SGAS1000
• 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	00860012112821 [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: 2024-06-17 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: 2024-06-17SafeGait Active S1000 system (Model SGAS1000) is designed to assist a patient with some impediments in walking/balance to exercise and/or to regain normal gait. SafeGait Active S1000 system tethers patients with a dedicated harness hanging from a powered pneumatic braking device on the overhead steel rails moved by pulling force from the patient. SafeGait Active S1000 system reduces clinician’s workload when helping patients to exercise or relearn the gait in a safe 3D environment. SafeGait Active S1000 system shall only be operated by trained clinicians, therapists or DIH staff.
• 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