Identity
- Trade Name
- Switch-It Dual Pro EUDAMEDFDA UDI
- Generic Name
- Wheelchair steering/control unit FDA UDI
- Device Name
- Switch IT EUDAMEDThe Dual Pro is a truly proportional head array with fine-tuned adjustments and configurability to provide the user an easy-to-learn, precise, and intuitive driving experience. FDA UDI
- Model / Reference
- Dual Pro EUDAMEDFDA UDI
- Description
- The Dual Pro is a truly proportional head array with fine-tuned adjustments and configurability to provide the user an easy-to-learn, precise, and intuitive driving experience. FDA UDI
Identifiers
- Catalog Number
- SWI FDA UDI
- Primary DI / UDI-DI
- 00016958060812 EUDAMEDFDA UDI
- Basic UDI-DI
- 0016958switchitEF EUDAMED
- Direct Marketing DI
- 00016958060812 EUDAMED
- FDA Product Code
- KNO FDA UDI
- EMDN Code
- Y122403 WHEELCHAIR FOOTRESTS, SUPPORTS AND CONTROLS EUDAMED
- GMDN Term
- Wheelchair steering/control unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3910 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Switch-It Dual Pro by Sunrise Medical (US) LLC — 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 | 0016958switchitEF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
- EUDAMED SRN
- US-MF-000007254
- Authorised Representative
- Sunrise Medical GmbH DE-AR-000006321
Sources (2)
- EUDAMED aa7cd129-755b-45d2-8c0a-b81dfc465fc4 61 fields · synced Jun 18, 2026
- FDA UDI 335c0cd4-5049-4707-9a5b-ca1e4211171b 34 fields · synced May 29, 2026