Identity
- Trade Name
- Cruiser FDA UDI
- Generic Name
- Transport wheelchair, collapsible FDA UDI
- Device Name
- Cruiser models are manual wheelchairs intended to provide mobility to a person with disabilities who is permanently or partially non-ambulatory and limited to a seated position. FDA UDI
- Model / Reference
- CX10T FDA UDI
- Description
- Cruiser models are manual wheelchairs intended to provide mobility to a person with disabilities who is permanently or partially non-ambulatory and limited to a seated position. FDA UDI
Identifiers
- Catalog Number
- 904851 FDA UDI
- Primary DI / UDI-DI
- 10840117400747 FDA UDI
- 510(k) Number
- K810676 FDA UDI
- FDA Product Code
- LBE FDA UDI
- GMDN Term
- Transport wheelchair, collapsible FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3850 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Attendant-only-propelled wheelchair, non-bariatricTransport wheelchair, collapsible
Cruiser by Convaid Products LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- Everest & Jennings — GF Health Products, Inc · Class I
Cleared under the same submission
K810676 also covers:
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Convaid Products LLC
Sources (2)
- FDA UDI bf151ea0-f3e4-4743-af68-16051b275fde 36 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026