FDA Registration
Active
🇩🇪 Germany
Omnistim FX2 Portable
Reg #: 3004929320
·
FEI: 3004929320
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- TIC MEDIZINTECHNIK GMBH&CO.KG
- Registration Number
- 3004929320
- FEI Number
- 3004929320
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Endelner Feld 9
- City
- Dorsten North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K821523
Owner / Operator
- Firm Name
- tic Medizintechnik GmbH&Co.KG
- Operator Number
- 10024525
- Address
- Endelner Feld 9
- City
- Dorsten
- State
- North Rhine-Westphalia
- Postal Code
- 46286
- Country
- DE
- Correspondent
- Christian Kleeberg
US Agent
- Business Name
- Accelerated Care Plus
- Contact Name
- Lee Grasseschi
- Address
- 1170 Trademark Dr Ste 104
- City
- Reno
- State
- NV
- ZIP
- 89521
- Country
- US
- [email protected]
- Phone
- 775 2231391
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2009-08-10 |
Proprietary Names
Omnistim FX2 Portable
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device