FDA UDI
In Commercial Distribution
🇺🇸 United States
Recline (2pt) Adjustable Height Armrest Assy
DI: 07540147002602
·
Model: D-0127-RC
·
Motion Concepts Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Recline (2pt) Adjustable Height Armrest Assy
- Primary DI
- 07540147002602
- Version / Model
- D-0127-RC
- Catalog Number
- RC
- 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
- e1cd6e24-2274-4eab-b021-7f0d4e9ea236
Device Description
Recline (2-point) Adjustable Height Armrest Assembly attaches to the recline back cane and seat side frame. The Recline Armrest is designed to flip backward to provide clearance for side transfers. 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
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 | 07540147002602 | GS1 |
Customer Contacts
- Phone
- 1-888-433-6818
- [email protected]