Zippie GS EIZGS

GUDID 00016958045918

The Zippie® GS™ offers frame and component growth, standard and reverse wheel configurations, and folding and rigid frame wheelchair options to keep up with children's ever-changing lives.

SUNRISE MEDICAL (US) LLC

Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 00016958045918
• NIH Device Record Key: 66de1aa9-5a12-466c-b554-7722b263a39f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zippie GS
• Version Model Number: GS, GS SE
• Catalog Number: EIZGS
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00016958045918 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983639

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: 2024-02-02
• Device Publish Date: 2024-01-25

On-Brand Devices [Zippie GS]

• 00016958099126: The Zippie® GS™ offers frame and component growth, standard and reverse wheel configurations,
• 00016958045918: The Zippie® GS™ offers frame and component growth, standard and reverse wheel configurations,