Zippie Zone EIRZ1

GUDID 00016958056006

The Zippie® Zone® is an innovative, ultra lightweight, and option-rich pediatric rigid frame wheelchair that is perfect for active kids and teens. Designed for the unique needs of kids, the Zone offers numerous growth options and provides the greatest wheel access for independent mobility.

SUNRISE MEDICAL (US) LLC

Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 00016958056006
• NIH Device Record Key: 423617a5-a861-4e9f-96ae-330b986ffd0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zippie Zone
• Version Model Number: Zone
• Catalog Number: EIRZ1
• Company DUNS: 962525056
• Company Name: SUNRISE MEDICAL (US) 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00016958056006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973673

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: 2023-09-13
• Device Publish Date: 2023-09-05

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