The following data is part of a premarket notification filed by Ibramed Equipamentos Medicos with the FDA for Thermopulse.
Device ID | K131926 |
510k Number | K131926 |
Device Name: | THERMOPULSE |
Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
Applicant | IBRAMED EQUIPAMENTOS MEDICOS 18851 NE 29TH AVE 720 Aventura, FL 33180 |
Contact | Tara Conrad |
Correspondent | Tara Conrad IBRAMED EQUIPAMENTOS MEDICOS 18851 NE 29TH AVE 720 Aventura, FL 33180 |
Product Code | IMJ |
CFR Regulation Number | 890.5290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-26 |
Decision Date | 2014-07-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERMOPULSE 88169167 5947472 Live/Registered |
The trustees of the Thomas J. Rose and/or Tom Rose Living Trust 2018-10-25 |
THERMOPULSE 74736708 1998327 Dead/Cancelled |
Questech International, Inc. 1995-03-08 |
THERMOPULSE 74172671 1734384 Live/Registered |
SPRAYMATION INC. 1991-06-03 |
THERMOPULSE 72350977 0915675 Dead/Expired |
THERMOTRON CORPORATION 1970-02-09 |
THERMOPULSE 72243029 0853148 Dead/Expired |
SPRAYMATION, INC. 1966-04-08 |