FDA Registration
Active
🇺🇸 United States
PIVOT - EDM
Reg #: 3014903258
·
FEI: 3014903258
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- PIVOT - EDM
- Registration Number
- 3014903258
- FEI Number
- 3014903258
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12202 Cary Circle
- City
- La Vista
- State
- NE
- ZIP
- 68128
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242804
Owner / Operator
- Firm Name
- Pivot - EDM
- Operator Number
- 10061153
- Address
- 12202 Cary Circle
- City
- La Vista
- State
- NE
- Postal Code
- 68128
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Platform, Force-Measuring | KHX | Class 1 | Physical Medicine | No | 2019-08-30 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2021-12-01 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2019-08-30 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2025-07-02 |
Proprietary Names
Platform, Force-Measuring
Zibrio Pro; Zibrio SmartScale
5020 Console; 5025 Console
Otoscope
Otoscope - WiscMed Wispr
ASP-PUMP-120, PAL Aspiration Pump, 115V
ASP-UI, PAL Aspiration Pump Console
ASP-PUMP-240, PAL Aspiration Pump, 230V
PAL 7020 Console
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility