Amysystems atr

GUDID 00827482201738

Alltrack power wheelchair series

Amylior Inc

Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, non-collapsible Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 00827482201738
• NIH Device Record Key: 4db4ec3c-294e-4449-88db-35e1aecd8601
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amysystems
• Version Model Number: atr
• Catalog Number: atr
• Company DUNS: 259763985
• Company Name: Amylior 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827482201738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092225

FDA Product Code

• ITI: Wheelchair, Powered

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: 2017-10-10

On-Brand Devices [Amysystems]

• 00827482201769: Amyseat after market power seating system
• 00827482201752: Alltrack series power wheelchair
• 00827482201745: Alltrack series power wheelchair
• 00827482201738: Alltrack power wheelchair series
• 00827482201721: Alltrack power wheelchair series
• 00827482201714: Alltrack powerchairs series