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 |