Stimulator, Caloric-Water
The caloric-water stimulator is a diagnostic device that delivers measured volumes of warm or cool water into the ear canal to induce a caloric response in the vestibular system, used in the evaluation of vestibular function and balance disorders. It is classified as FDA Class 1, the lowest risk category, requiring only general controls. The product code is ETP, regulated under 21 CFR 874.1800 in the Ear, Nose, Throat specialty. No special regulatory flags apply.
Research product code ETP in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- ETP
- Device Class
- FDA class 1
- Regulation Number
- 874.1800
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K863615 | ENTHERMO IRRIGATION UNIT | Dec 16, 1986 | Substantially Equivalent | Jedmed Instrument Co. |
| K820775 | VESTIBULARISET | Nov 03, 1982 | Substantially Equivalent | Jedmed Instrument Co. |
| K821481 | NASAL-THROAT SPRAY IRRIGATION INSTRUM. | Jun 14, 1982 | Substantially Equivalent | Ethicare Products |
| K813552 | MODEL 3000C CALORIC IRRIGATOR | Feb 22, 1982 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K800443 | HYGROTHERM | Mar 10, 1980 | Substantially Equivalent | Jedmed Instrument Co. |
| K800442 | VARIOTHERM | Mar 10, 1980 | Substantially Equivalent | Jedmed Instrument Co. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.