The following data is part of a premarket notification filed by Viatherm Therapeutics, Llc. with the FDA for Viatherm Boost.
| Device ID | K173300 |
| 510k Number | K173300 |
| Device Name: | ViaTherm BOOST |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | ViaTherm Therapeutics, Llc. 201 Defense Highway Suite 260 Annapolis, MD 21401 |
| Contact | Michael J. Thomas |
| Correspondent | Melissa Walker Graematter, Inc. 1324 Clarkson Clayton Center #332 St. Louis, MO 63011 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-17 |
| Decision Date | 2018-05-01 |
| Summary: | summary |