The following data is part of a premarket notification filed by Bloomex International, Inc. with the FDA for Slendertone.
Device ID | K790120 |
510k Number | K790120 |
Device Name: | SLENDERTONE |
Classification | Stimulator, Muscle, Powered |
Applicant | BLOOMEX INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-23 |
Decision Date | 1979-05-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SLENDERTONE 77506546 3569743 Dead/Cancelled |
Morton, Victoria M. 2008-06-24 |
SLENDERTONE 73313012 1289384 Dead/Cancelled |
Bio-Medical Research Limited 1981-06-03 |
SLENDERTONE 73279029 not registered Dead/Abandoned |
SLENDERTONE BEAUTY CENTERS INC. 1980-09-23 |
SLENDERTONE 73270417 1293781 Live/Registered |
Bio-Botanica, Inc. 1980-07-16 |
SLENDERTONE 73209399 1180968 Live/Registered |
Slendertone Limited 1979-03-29 |