FDA UDI
In Commercial Distribution
🇺🇸 United States
MOBILITY ASSIST
DI: 00718175005705
·
Model: 950-570
·
BIODEX MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MOBILITY ASSIST
- Primary DI
- 00718175005705
- Version / Model
- 950-570
- Catalog Number
- 950-570
- Company Name
- BIODEX MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 043833813
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-10
- Public Version
- 1
- Public Version Date
- 2019-06-18
- Public Version Status
- New
- Public Device Record Key
- acbae2aa-b92a-423f-8828-1fa3c3175e18
Device Description
Mobility Assist
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
- Yes
- 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 |
|---|---|---|---|---|
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63674 | Gait rehabilitation electronic walker | An all-wheeled, battery-powered device designed to assist a patient with a walking disability (neurogenic, muscular, or orthopaedic in origin) to regain lost motor function, which may include rising from sitting to standing and/or ambulation over ground (not on a treadmill). It consists of a mobile rigid framework, on non-powered wheels, which includes a platform intended for forearm/elbow support and a patient harness; handgrips; and an electronic control unit for powered functions such as variable height support. It is intended to be used in a clinical setting (e.g., gait lab, rehabilitation centre, nursing home) under healthcare professional supervision. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00718175005705 | GS1 |