|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
jkh stimulator plus
|
JKH USA, LLC
|
K182203 |
03/14/2019
|
jkh stimulator plus
|
JKH USA, LLC
|
K191151 |
06/21/2019
|
katalyst mark 1 muscle stimulation system
|
Katalyst Inc.
|
K171035 |
09/06/2017
|
katalyst mark 1 muscle stimulation system model 2
|
Katalyst Inc.
|
K181199 |
09/20/2018
|
katalyst training system
|
Katalyst Inc.
|
K190966 |
02/03/2020
|
legend pro dma
|
Pollogen, Ltd
|
K200545 |
10/21/2021
|
legend x platform
|
Pollogen Ltd
|
K232903 |
10/17/2023
|
li-battery powered otc tens/ems combination stimulator
|
Everyway Medical Instruments Co., Ltd
|
K201335 |
10/24/2020
|
li-battery powered otc tens/ems, model em-6000, em-6100, em-6200 & em-6300
|
Everyway Medical Instruments Co., Ltd.
|
K202470 |
11/25/2020
|
li-battery powered otc tens/ems, model ev-804, model ev-805, & model ev-806
|
Everyway Medical Instruments Co., Ltd.
|
K202317 |
11/13/2020
|
|