FDA UDI
In Commercial Distribution
🇺🇸 United States
Push-Button Style Pelvic Lap Belt
DI: 07540147002992
·
Model: D-0178-BELT
·
Motion Concepts Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Push-Button Style Pelvic Lap Belt
- Primary DI
- 07540147002992
- Version / Model
- D-0178-BELT
- Catalog Number
- BELT
- Company Name
- Motion Concepts Inc
- Labeler DUNS
- 259777209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-22
- Public Version
- 3
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 0890f424-c15d-4205-834a-6ef4debde0e4
Device Description
Push-button pelvic lap belt for use on Motion Concepts UL Maxx wheelchair seating systems equipped with Ultra-Rails. Lap belts are available in 4 sizes (lengths): 35", 48", 60" and 71". (Mounting hardware is included). IMPORTANT: Pelvic lap belts are provided for postural support only and are NOT suitable for use as vehicle safety belt during occupied transport in a wheelchair.
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 |
|---|---|---|---|---|
| IQB | Belt, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13356 | Wheelchair/chair/stander occupant restraint/support | A rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair/stander and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle. This device may also include the extensions needed to attach this device and may be available in various sizes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540147002992 | GS1 |
Customer Contacts
- Phone
- 1-888-433-6818
- [email protected]