FDA UDI
In Commercial Distribution
🇺🇸 United States
PHTSIOGAIT US
DI: 05903684803286
·
Model: non-AC-powerd
·
MEDEN INMED SP Z O O
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PHTSIOGAIT US
- Primary DI
- 05903684803286
- Version / Model
- non-AC-powerd
- Catalog Number
- 01-ELV-0105-001
- Company Name
- MEDEN INMED SP Z O O
- Labeler DUNS
- 367142903
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-07
- Public Version
- 1
- Public Version Date
- 2022-11-15
- Public Version Status
- New
- Public Device Record Key
- 4221b7f2-3da3-45c7-b9aa-2dbf408eaef6
Device Description
PhysioGait Dynamic Partial Weight Bearing system is intended to accomplish dynamic patient support used in the rehabilitation and gait reeducation. The device is used for therapeutic and diagnostic purposes (training balance and gait). It is ideal for working with neurological and orthopedic patients, both adults and children.
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
- Yes
- 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 |
|---|---|---|---|---|
| FSA | Lift, Patient, Non-Ac-Powered | General Hospital | 880.5510 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45675 | Fixed patient lifting system, manual | A non-powered, fixed assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort within an area limited by the lifting radius of the system. Also known as a patient hoist, it typically consists of a support base fixed permanently to a ceiling, wall, floor, or piece of equipment such as a bath or the edge of a swimming pool, with a lifting mechanism, mast, boom/lifting arm(s), swivel bar, and patient holding device (e.g., a sling, holder or a frame). The lifting mechanism provides mechanical advantage (e.g., using pneumatic springs) to aid manual movement of components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05903684803286 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 135 | Centimeter | |
| Height | 234 | Centimeter | |
| Height | 210 | Centimeter |