Identity
- Trade Name
- Cool Cube / TouchDrive 2 FDA UDI
- Generic Name
- Wheelchair steering/control unit FDA UDI
- Device Name
- The Cool Cube™ central hub input ports interface with multiple types of switches and can effectively control the various desired switch functions. The Switch-It TouchDrive2 (currently not in distribution) uses proven cell phone touchscreen technology for ultra-sensitive and precise proportional driving capabilities for wheelchair control. FDA UDI
- Model / Reference
- CCB / TD2 FDA UDI
- Description
- The Cool Cube™ central hub input ports interface with multiple types of switches and can effectively control the various desired switch functions. The Switch-It TouchDrive2 (currently not in distribution) uses proven cell phone touchscreen technology for ultra-sensitive and precise proportional driving capabilities for wheelchair control. FDA UDI
Identifiers
- Catalog Number
- SWI FDA UDI
- Primary DI / UDI-DI
- 00016958058413 FDA UDI
- FDA Product Code
- KNN FDA UDI
- GMDN Term
- Wheelchair steering/control unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3920 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair steering/control unit
Cool Cube / TouchDrive 2 by Sunrise Medical (US) LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wheelchair steering/control unit.
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- Remote Stop Switch — Sunrise Medical (US) LLC · Class I
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 5c4cb579-1a6c-476a-ba28-dc442c1b6b41 34 fields · synced Jun 9, 2026