Invacare Essentials EX1 IEX106DAEL

GUDID 00841447114758

Essential EX1 20 x 16 Desk Arms Elevating Legrests

INVACARE CORPORATION

Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 00841447114758
• NIH Device Record Key: 805ded07-cdad-4a65-bd0e-dee97cb48f1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invacare Essentials EX1
• Version Model Number: IEX106DAEL
• Catalog Number: IEX106DAEL
• 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: false
• OTC Over-The-Counter: true

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841447114758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052468

FDA Product Code

• IOR: Wheelchair, Mechanical

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: 2024-09-23
• Device Publish Date: 2024-09-15

On-Brand Devices [Invacare Essentials EX1]

• 00841447114758: Essential EX1 20 x 16 Desk Arms Elevating Legrests
• 00841447114741: Essential EX1 18 x 16 Desk Arms Elevating Legrests
• 00841447114734: Essential EX1 16 x 16 Desk Arms Elevating Legrests
• 00841447114727: Essential EX1 20 x 16 Desk Arms Swing Away Footrests
• 00841447114697: Essential EX1 18 x 16 Desk Arms Swing Away Footrests
• 00841447114680: Essential EX1 16 x 16 Desk Arms Swing Away Footrests