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

Devices Manufactured by SUNRISE MEDICAL (US) LLC

• 00016958059366 - Empluse: 2024-08-01 The R20 device is intended to be used by the assistant of a wheelchair user to aid in the propulsion of the chair and user over
• 00016958059465 - Empulse: 2024-07-04 The R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual prop
• 00016958045918 - Zippie GS: 2024-02-02 The Zippie® GS™ offers frame and component growth, standard and reverse wheel configurations, and folding and rigid frame whe
• 00016958057034 - Zippie X'Cape: 2024-02-02 The ZIPPIE X’CAPE® pediatric folding wheelchair is the first ever wheelchair with XLOCK® technology for the performance of a
• 00016958057041 - Quickie 5R: 2024-02-02 The Quickie® 5R is designed to deliver superior rigid wheelchair performance day after day. As you and your environment evolve,
• 00016958047349 - Zippie TS SE: 2023-11-22 The Zippie® TS is the original, premier pediatric tilt-in-space wheelchair. Available with either a folding or rigid frame, bui
• 00016958060850 - Switch-it: 2023-11-22 The Ctrl+5 box allows you to easily access power seating controls right at your fingertips. Designed with five buttons or toggle
• 00016958047325 - Jay: 2023-11-20 JAY® Fit Seating simplifies the world of made-to-order seating by offering a "semi-personalized" solution. A great option for i