|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
cooltone
|
Zimmer MedizinSysteme GmbH
|
K220601 |
04/01/2022
|
tens & pms (model:sm9009, sm9021, sm9128h, sm9015, sm9055, sm9033)
|
Hong Qiangxing (Shen Zhen) Electronics Limited
|
K220283 |
05/02/2022
|
transcutaneous electrical nerve stimulator, model: ktr-405
|
Shenzhen Kentro Medical Electronics Co., Ltd.
|
K220998 |
08/24/2022
|
visionbody
|
VB Technologies AG
|
K222386 |
02/24/2023
|
wireless tens/ems, bruno, aela
|
ZMI Elecronics Ltd.
|
K220997 |
09/01/2022
|
xbody go usa, xbody pro usa
|
XBody Hungary Kft.
|
K221200 |
01/31/2023
|
nova hd+
|
Aura Wellness, LLC
|
K220938 |
08/22/2023
|
nuera tight rf family
|
BIOS s.r.l.
|
K223856 |
08/11/2023
|
starformer, tightwave
|
Fotona d.o.o.
|
K221274 |
09/29/2023
|
tens & pms (model:sm9089, sm9587, sm9592, sm9555)
|
Hong Qiangxing (Shen Zhen) Electronics Limited
|
K220152 |
04/19/2022
|
|