Data / Medical devices / Germany / Gbo Medizintechnik AG
Gbo Medizintechnik AG: FDA-registered device maker in Rimbach Hesse, Germany, 2 510(k) clearances
Gbo Medizintechnik AG is registered with the FDA (registration 3005095860) in Rimbach Hesse, Germany. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 2, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005095860
- Address
- Kleiststrasse 6, Rimbach Hesse, Germany, 64668
- Owner or operator
- gbo Medizintechnik AG (10087227)
- Roles
- Manufacturer
- First device listed
- January 31, 2023
- Registered through
- 2027
- Brand names listed
- HiToP® 1touch, HiToP® 2touch, HiToP® 4touch, HiToP® PNP, TESI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interferential Current Therapy | LIH | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 2026 | K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | IPF | Substantially Equivalent | Mohammadali Nezakati | accessdata.fda.gov |
| January 17, 2023 | K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | IPF | Substantially Equivalent | Hilltek, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered
- All makers of Interferential Current Therapy
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Massager, Therapeutic, Electric
Updated June 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.