The following data is part of a premarket notification filed by Zenith Technical Innovations with the FDA for Therm-x Pro, Therm-x At, Therm-x Pro Athlete.
| Device ID | K181149 |
| 510k Number | K181149 |
| Device Name: | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete |
| 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) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2018-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850001096089 | K181149 | 000 |
| 00850001096003 | K181149 | 000 |
| 00850001096010 | K181149 | 000 |
| 00850001096027 | K181149 | 000 |
| 00850001096034 | K181149 | 000 |
| 00850001096041 | K181149 | 000 |
| 00850001096058 | K181149 | 000 |
| 00850001096065 | K181149 | 000 |
| 00850001096072 | K181149 | 000 |
| 00850001096294 | K181149 | 000 |