Identity
- Trade Name
- Switch-It Head Controls-External FDA UDI
- Generic Name
- Wheelchair steering/control unit FDA UDI
- Device Name
- Switch-It traditional switched head arrays use zero-touch proximity sensors which are specifically designed for power wheelchair application and are less susceptible to interference from high electromagnetic fields generated by power wheelchairs. FDA UDI
- Model / Reference
- Head Control FDA UDI
- Description
- Switch-It traditional switched head arrays use zero-touch proximity sensors which are specifically designed for power wheelchair application and are less susceptible to interference from high electromagnetic fields generated by power wheelchairs. FDA UDI
Identifiers
- Catalog Number
- SWI FDA UDI
- Primary DI / UDI-DI
- 00016958058420 FDA UDI
- FDA Product Code
- KNO FDA UDI
- GMDN Term
- Wheelchair steering/control unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3910 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair steering/control unit
Switch-It Head Controls-External by Sunrise Medical (US) LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 4be62b37-f5e0-491e-914a-93a73da7fc91 34 fields · synced Jun 9, 2026