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Zephyr Hoverboards & Accessories
EUDAMEDFDA UDIClass I (EU MDR)
Ref ZEP-AFR-20
by Diacor Inc.
Identity
- Trade Name
- Zephyr Patient Positioning and Transfer System FDA UDI
- Generic Name
- Patient lifting system stretcher FDA UDI
- Device Name
- Zephyr Hoverboards & Accessories EUDAMEDZEPHYR HDR ACCESSORY - FOOTREST, MRI FDA UDI
- Model / Reference
- ZEP-AFR-20 EUDAMEDFDA UDI
- Description
- ZEPHYR HDR ACCESSORY - FOOTREST, MRI FDA UDI
Identifiers
- Primary DI / UDI-DI
- B237ZEPAFR200 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B237HOVERBOARDV7 EUDAMED
- 510(k) Number
- K121929 FDA UDI
- FDA Product Code
- FRZ FDA UDI
- EMDN Code
- V080504 PATIENT TRANSFER BOARDS AND TABLES EUDAMED
- GMDN Term
- Patient lifting system stretcher FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6775 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Zephyr Hoverboards & Accessories by Diacor Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B237HOVERBOARDV7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diacor Inc.
- EUDAMED SRN
- US-MF-000017181
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED 49cd8702-dd20-4cb3-bac0-59e8776fb934 61 fields · synced Jun 20, 2026
- FDA UDI 392a6486-dae6-4652-8cfb-998d05ed7f47 34 fields · synced May 30, 2026