FDA UDI
In Commercial Distribution
🇺🇸 United States
DIERS pedogait
DI: 04260242060132
·
Model: n/a
·
DIERS International GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DIERS pedogait
- Primary DI
- 04260242060132
- Version / Model
- n/a
- Company Name
- DIERS International GmbH
- Labeler DUNS
- 499189983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-02
- Public Version
- 1
- Public Version Date
- 2023-06-12
- Public Version Status
- New
- Public Device Record Key
- 78de560d-d9d8-49f1-9621-d0a4c18aedba
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
- Yes
- 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 |
|---|---|---|---|---|
| KHX | Platform, Force-Measuring | Physical Medicine | 890.1575 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33015 | Standard treadmill, powered | A mains electricity (AC-powered) device designed to facilitate in-place walking, jogging, or running to promote muscle redevelopment, to restore motion to joints, and to promote weight loss and cardiovascular fitness. It consists of an endless, continuous track (e.g., a shock-absorbing rubber belt rotating on rollers) on which the patient exercises that can be set to rotate at varying speeds, electric motors, and a control unit (to regulate belt speed/elevation, display related data, and activate an emergency stop). It will typically incorporate front and side-mounted rails to allow patients to steady themselves while in motion. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260242060132 | GS1 |