FDA UDI
In Commercial Distribution
🇺🇸 United States
Dual Post Outback Tilt Armrest Assy
DI: 07540147002626
·
Model: D-0214-OAT
·
Motion Concepts Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dual Post Outback Tilt Armrest Assy
- Primary DI
- 07540147002626
- Version / Model
- D-0214-OAT
- Catalog Number
- OAT
- Company Name
- Motion Concepts Inc
- Labeler DUNS
- 259777209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- de109d59-47f9-4a25-b9fe-461b6cc7b1cb
Device Description
The Dual Post Outback Tilt Armrest (lower) Assembly mounts to the seat side rail of the Motion Concepts power positioning system configured with a Tilt function. The outback design allows the armrest to rotate outward and backwards to provide maximum clearance for side transfers. (The Upper Dual Post Armrest Tube Assy is sold separately). Left and Right Armrest configurations are available.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IML | Armrest, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32981 | Wheelchair armrest | A small platform, typically cushioned, mounted on the lateral ends of a wheelchair to provide the user with a support on which to place the arms. The position of the platform (e.g., height) may be adjustable to suit the comfort and utility of the user. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540147002626 | GS1 |
Customer Contacts
- Phone
- 1-888-433-6818
- [email protected]