Zippie TS SE EIZ1A

GUDID 00016958047349

The Zippie® TS is the original, premier pediatric tilt-in-space wheelchair. Available with either a folding or rigid frame, built-in growth, and compatible with many seating and positioning solutions, the TS has the widest variety of options in the tilt-in-space market.

SUNRISE MEDICAL (US) LLC

Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 00016958047349
• NIH Device Record Key: 61de7214-a41d-4342-9a5e-363995a3211a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zippie TS SE
• Version Model Number: TS SE
• Catalog Number: EIZ1A
• 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	00016958047349 [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: 2023-11-22
• Device Publish Date: 2023-11-14

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