Identity
- Trade Name
- Zippie Zone FDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Zone FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- EIRZ1 FDA UDI
- Primary DI / UDI-DI
- 00016958056006 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Push-rim manual wheelchair, non-bariatric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Push-rim manual wheelchair, non-bariatric
Zippie Zone by Sunrise Medical (US) LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Push-rim manual wheelchair, non-bariatric.
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- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
Sources (1)
- FDA UDI 423617a5-a861-4e9f-96ae-330b986ffd0b 34 fields · synced Jun 9, 2026