Amigo

GUDID 00863048000322

Amigo HD

AMIGO MOBILITY INTERNATIONAL, INC.

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• Primary Device ID: 00863048000322
• NIH Device Record Key: 6202a89a-ba3d-4a5c-8f66-34aeaa29ab4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amigo
• Version Model Number: HD
• Company DUNS: 160430757
• Company Name: AMIGO MOBILITY INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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	00863048000322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K871391

FDA Product Code

• INF: Scale, Platform, Wheelchair

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [Amigo]

• 00863048000346: Amigo Escort 7.5
• 00863048000339: Amigo Classic FD
• 00863048000322: Amigo HD
• 00863048000315: Amigo RT Express
• 00863048000308: Amigo RD