|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
sunmas tens & pms (model sm9187, sm9180l, sm9180s)
|
Hong Qiangxing (Shen Zhen) Electronics Limited
|
K190009 |
12/02/2019
|
cooltone
|
Zimmer MedizinSysteme GmbH
|
K192940 |
11/15/2019
|
hivox spopad ems sp-911, sp-921
|
Hivox Biotek Inc.
|
K192264 |
11/08/2019
|
combo electrotherapy device
|
Shenzhen Roundwhale Technology Co., Ltd.
|
K192087 |
11/01/2019
|
electronic pulse stimulator
|
Shenzhen Leading Perfection Technology Co., Ltd
|
K183674 |
10/11/2019
|
nxpro neuromuscular electrical stimulation device
|
NeuX Technologies, Inc.
|
K191181 |
10/11/2019
|
intelligent wireless fitness apparatus (model: ast-301, ast-302, ast-303)
|
Shenzhen OSTO Technology Co., Ltd.
|
K182136 |
10/10/2019
|
ems belt (model mc0485)
|
Dongguan Yingfeng Metal & Plastic Products Co., Ltd
|
K183103 |
09/18/2019
|
gim-stim otc tens/ems system
|
Gemore Technology Co Ltd
|
K190988 |
08/16/2019
|
transcutaneous electrical nerve stimulator
|
Shenzhen Kentro Medical Electronics Co., Ltd
|
K183288 |
07/30/2019
|