|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
otc combo tens/ems system
|
Well-Life Healthcare Limited
|
K172809 |
10/18/2017
|
well life wireless tens/ems stimulator, models wr-2605/2605a
|
WELL-LIFE HEALTHCARE LIMITED
|
K161453 |
12/05/2016
|
well-life otc ems system
|
WELL-LIFE HEALTHCARE LIMITED
|
K102786 |
07/01/2011
|
otc abdomen & thigh system, model: wl-2410, wl-2411 and wl-2412
|
WELL-LIFE HEALTHCARE LIMITED
|
K072168 |
12/19/2007
|
gymform abs-a-round
|
WELL BRAIN INTERNATIONAL, LTD.
|
K130074 |
08/15/2013
|
gymform abs & core
|
WELL BRAIN INTERNATIONAL, LTD.
|
K142055 |
05/11/2015
|
gymform dual flex belt model wb-162
|
WELL BRAIN INTERNATIONAL, LTD.
|
K111781 |
07/11/2012
|
gymform total abs
|
Well Brain International Ltd.
|
K202653 |
01/15/2021
|
venus blissmax
|
Venus Concept USA Inc.
|
K213308 |
01/12/2022
|
venus blissmax
|
Venus Concept USA Inc.
|
K220592 |
04/27/2022
|