The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Variotherm.
| Device ID | K800442 |
| 510k Number | K800442 |
| Device Name: | VARIOTHERM |
| Classification | Stimulator, Caloric-water |
| Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETP |
| CFR Regulation Number | 874.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-28 |
| Decision Date | 1980-03-10 |