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Zephyr Patient Positioning and Transfer System
FDA UDIEUDAMEDClass II (US FDA UDI)
by Diacor Inc.
Identity
- Trade Name
- Zephyr Patient Positioning and Transfer System FDA UDI
- Generic Name
- Patient transfer system, powered FDA UDI
- Device Name
- Zephyr XL Patient Hover Board 50cm FDA UDI
- Model / Reference
- ZXL-4 FDA UDI
- Description
- Zephyr XL Patient Hover Board 50cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B237ZXL40 FDA UDI
- 510(k) Number
- K121929 FDA UDI
- FDA Product Code
- FRZ FDA UDI
- GMDN Term
- Patient transfer system, powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6775 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
MR Safe FDA UDI
Zephyr Patient Positioning and Transfer System by Diacor Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diacor Inc.
Sources (2)
- FDA UDI 50f71326-563b-48cc-921b-ec9746f5c176 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 28, 2026