The following data is part of a premarket notification filed by Zenith Technical Innovations with the FDA for Therm-x.
| Device ID | K193550 |
| 510k Number | K193550 |
| Device Name: | Therm-X |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Zenith Technical Innovations 1396 St. Paul Ave. Gurnee, IL 60031 |
| Contact | Greg Binversie |
| Correspondent | Rita King MethodSense, Inc. 1 Copley Parkway Suite 410 Morrisville, NC 27560 |
| Product Code | IRP |
| Subsequent Product Code | ILO |
| Subsequent Product Code | JOW |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Physical Medicine |
| 510k Review Panel | Physical Medicine |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-02-28 |