INVACARE® FDX® POWER WHEELCHAIR

GUDID 00841447101208

INVACARE CORPORATION

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 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 Electric-motor-driven wheelchair, occupant-controlled Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 00841447101208
• NIH Device Record Key: f4de8a2c-40f4-487b-8e1b-3bce66094a35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INVACARE® FDX® POWER WHEELCHAIR
• Version Model Number: ATO_FDX-MCG
• Company DUNS: 076916246
• Company Name: INVACARE CORPORATION
• 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: 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

Customer Support Contacts

• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841447101208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991168

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: 2016-08-15

On-Brand Devices [INVACARE® FDX® POWER WHEELCHAIR]

• 00841447101604: ATO_FDX
• 00841447101284: ATO_FDX-CG
• 00841447101208: ATO_FDX-MCG
• 00841447101178: FDX
• 00841447100959: FDX-CG
• 00841447100881: FDX-MCG