Gait Trainer 3 950-403

GUDID 00718175005439

Gait Trainer 3, 230 VAC with Extended Handrails

BIODEX MEDICAL SYSTEMS, INC.

Standard treadmill, powered

• Primary Device ID: 00718175005439
• NIH Device Record Key: 3422b469-27fb-4f7d-8699-fc781044d0ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gait Trainer 3
• Version Model Number: 950-403
• Catalog Number: 950-403
• Company DUNS: 043833813
• Company Name: BIODEX MEDICAL SYSTEMS, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00718175005439 [Primary]

FDA Product Code

• IOL: Treadmill, 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: 2018-05-31
• Device Publish Date: 2018-04-30

On-Brand Devices [Gait Trainer 3]

• 00718175005484: Gait Trainer 3, 100 VAC, with Geriatric / Pediatric Handrails
• 00718175005477: Gait Trainer 3, 230, with Geriatric / Pediatric Handrails
• 00718175005460: Gait Trainer 3, 115 VAC, 50/60 Hz with Geriatric / Pediatric Handrails
• 00718175005453: Gait Trainer 3, 100 VAC, with Extended Handrails
• 00718175005446: Gait Trainer 3, 100 VAC
• 00718175005439: Gait Trainer 3, 230 VAC with Extended Handrails
• 00718175005422: Gait Trainer 3, 115 VAC, 12.1" LCD with Extended Handrails
• 00718175005415: Gait Trainer 3, 230 VAC
• 00718175005408: Gait Trainer 3, 115 VAC, 50/60 Hz