The following data is part of a premarket notification filed by Bio-medical Research Ltd. with the FDA for Slendertone® Connect Abs, Type 570.
| Device ID | K161974 |
| 510k Number | K161974 |
| Device Name: | SLENDERTONE® Connect Abs, Type 570 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Bio-Medical Research Ltd. Parkmore Business Park West Galway, IE H91 Nht7 |
| Contact | Anne-marie Keenan |
| Correspondent | Anne-marie Keenan Bio-Medical Research Ltd. Parkmore Business Park West Galway, IE H91 Nht7 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2016-11-01 |
| Summary: | summary |
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 |