Data / Medical devices / Germany / Tec Com Medizintechnik GMBH
Tec Com Medizintechnik GMBH: FDA-registered device maker in Kabelsketal Saxony-Anhalt, Germany, 1 510(k) clearance
Tec Com Medizintechnik GMBH is registered with the FDA (registration 3016507522) in Kabelsketal Saxony-Anhalt, Germany. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 14, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016507522
- Address
- Am Kruemmling 1, Kabelsketal Saxony-Anhalt, Germany, 06184
- Owner or operator
- Tec Com Medizintechnik GmbH (10061013)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 6, 2019
- Registered through
- 2026
- Brand names listed
- TECOtherm NEO, TECOtherm Wrabbit L, TECOtherm Wrabbit M, TECOtherm Wrabbit S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Mattress, Water, Temperature Regulated | FOH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 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 |
|---|---|---|---|---|---|---|
| November 14, 2014 | K140078 | TECOTHERM NEO (T NEO) | DWJ | Substantially Equivalent | Inspiration Healthcare, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mattress, Water, Temperature Regulated
- All makers of System, Thermal Regulating
- All makers of Bedding, Disposable, Medical
Updated November 14, 2014. 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.