FDA Registration
Active
🇩🇪 Germany
GBO MEDIZINTECHNIK AG
Reg #: 3005095860
·
FEI: 3005095860
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- GBO MEDIZINTECHNIK AG
- Registration Number
- 3005095860
- FEI Number
- 3005095860
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Kleiststrasse 6
- City
- Rimbach Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K213655
Owner / Operator
- Firm Name
- gbo Medizintechnik AG
- Operator Number
- 10087227
- Address
- Kleiststrasse 6
- City
- Rimbach
- State
- Hesse
- Postal Code
- 64668
- Country
- DE
US Agent
- Business Name
- HILLTEK LLC
- Contact Name
- Mohammadali Nezakati
- Address
- 65 Enterprise Ste 400
- City
- Aliso Viejo
- State
- CA
- ZIP
- 92656
- Country
- US
- [email protected]
- Phone
- 206 4069390
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2023-01-31 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2023-01-31 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2023-01-31 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2023-03-07 |
Proprietary Names
HiToP® 1touch
HiToP® 4touch
HiToP® 2touch
TESI
HiToP® PNP
Establishment Types
Manufacture Medical Device