TSUNAMI ALX TSUALX

GUDID 00850013379057

TSUNAMI RIGID MANUAL WHEELCHAIR

KI MOBILITY, LLC

Wheelchair, occupant-driven, rear-wheels-operated, non-collapsible

• Primary Device ID: 00850013379057
• NIH Device Record Key: aedec229-ea82-4d4d-aa2d-2213348d5281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSUNAMI ALX
• Version Model Number: ALX
• Catalog Number: TSUALX
• Company DUNS: 609305656
• Company Name: KI MOBILITY, LLC
• 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: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: 1-800-981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com
• Phone: +1(800)981-1540
• Email: sales@kimobility.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013379057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062660

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: 2020-09-29
• Device Publish Date: 2020-09-21

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• 00840363361758 - Star Standard Air: 2024-04-18 Standard Air Cushion 19.25" x 21" x 3"
• 00840363361765 - Star Standard Air: 2024-04-18 Standard Air Cushion 21" x 17.25" x 3"
• 00840363360003 - Star Stabil Air: 2024-04-17 Stabil Air Cushion 13.5" x 13.5" x 3"
• 00840363360010 - Star Stabil Air: 2024-04-17 Stabil Air Cushion 13.5" x 15.5" x 3"
• 00840363360027 - Star Stabil Air: 2024-04-17 Stabil Air Cushion 15.5" x 15.5" x 3"
• 00840363360034 - Star Stabil Air: 2024-04-17 Stabil Air Cushion 15.5" x 17.25" x 3"
• 00840363360041 - Star Stabil Air: 2024-04-17 Stabil Air Cushion 15.5" x 19.25" x 3"
• 00840363360058 - Star Stabil Air: 2024-04-17 Stabil Air Cushion 17.25" x 15.5" x 3"