|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
wireless tens/ems, bruno, aela
|
ZMI Elecronics Ltd.
|
K220997 |
09/01/2022
|
cooltone
|
Zimmer MedizinSysteme GmbH
|
K220601 |
04/01/2022
|
cooltone
|
Zimmer MedizinSysteme GmbH
|
K192940 |
11/15/2019
|
emfieldpro
|
Zimmer MedizinSysteme GmbH
|
K182963 |
06/21/2019
|
xbody newave usa
|
XBody Hungary Kft.
|
K190038 |
04/05/2019
|
xbody go usa, xbody pro usa
|
XBody Hungary Kft.
|
K221200 |
01/31/2023
|
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
|
buttock muscle stimulator model wl-2413b; buttock muscle stimulator mode wl-2413e
|
WELL-LIFE HEALTHCARE LIMITED
|
K123075 |
07/11/2013
|