Data / Medical devices / Stimulator, Caloric-Water
Stimulator, Caloric-Water (ETP): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Stimulator, Caloric-Water (product code ETP, Class 1, 21 CFR 874.1800). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on December 16, 1986, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ETP
- Device class
- 1
- Regulation
- 874.1800
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| Germany | 2 |
| Poland | 1 |
| Denmark | 1 |
| Belgium | 1 |
Makers of Stimulator, Caloric-Water
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Atmos Medizintechnik GMBH & Co. KG | LENZKIRCH Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DGS Diagnostics Sp. z o.o | Kolbaskowo Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Happersberger Otopront GMBH | Hohenstein Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Interacoustics A/S | Middelfart Syddanmark, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S.A. Instrumentation Difra | Eupen Liege, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 16, 1986. 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.