Identity
- Trade Name
- Outback Recline (2pt) Armrest Assy FDA UDI
- Generic Name
- Wheelchair armrest FDA UDI
- Device Name
- Outback Recline (2-point) Armrest Assembly attaches to the recline back cane and seat side frame. Outback design allows armrest to flip outward and backwards to provide maximum clearance for side transfers. Height Adjustable. Two height ranges available (9"-13" or 13"-16"). Left and Right armrest configurations available. Optional wheelchair component for use with Motion Concepts power positioning systems FDA UDI
- Model / Reference
- D-0214-OAR FDA UDI
- Description
- Outback Recline (2-point) Armrest Assembly attaches to the recline back cane and seat side frame. Outback design allows armrest to flip outward and backwards to provide maximum clearance for side transfers. Height Adjustable. Two height ranges available (9"-13" or 13"-16"). Left and Right armrest configurations available. Optional wheelchair component for use with Motion Concepts power positioning systems FDA UDI
Identifiers
- Catalog Number
- OAR FDA UDI
- Primary DI / UDI-DI
- 07540147002541 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 Recline (2pt) 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 5de936c3-40c8-4cbd-8457-bff8335bd258 35 fields · synced Jun 8, 2026