Identity
- Trade Name
- Outback Tilt Cantilever Adjustable Armrest Assy FDA UDI
- Generic Name
- Wheelchair armrest FDA UDI
- Device Name
- The Outback Tilt Cantilever Height and Angle Adjustable Armrest Assembly mounts to the tilt back canes on a Motion Concepts power positioning system configured with Tilt. The outback design allows the armrest to rotate outward and backwards to provide maximum clearance for side transfers. (Armrest is available in 3 adjustable height ranges: 7"-9", 9"-12", 12"-15"). FDA UDI
- Model / Reference
- D-0214-OCTA FDA UDI
- Description
- The Outback Tilt Cantilever Height and Angle Adjustable Armrest Assembly mounts to the tilt back canes on a Motion Concepts power positioning system configured with Tilt. The outback design allows the armrest to rotate outward and backwards to provide maximum clearance for side transfers. (Armrest is available in 3 adjustable height ranges: 7"-9", 9"-12", 12"-15"). FDA UDI
Identifiers
- Catalog Number
- OCTA FDA UDI
- Primary DI / UDI-DI
- 07540147002633 FDA UDI
- FDA Product Code
- IML FDA UDI
- GMDN Term
- Wheelchair armrest 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
No
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 armrest
Outback Tilt Cantilever Adjustable Armrest Assy by Motion Concepts Inc — 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
- Motion Concepts Inc
Sources (1)
- FDA UDI b52887ab-7fa2-4a00-98a3-0ac9313d8757 35 fields · synced Jun 1, 2026