|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
combo electrotherapy device
|
Shenzhen Roundwhale Technology Co., Ltd.
|
K192087 |
11/01/2019
|
fastfit ems system
|
Fast Fit LLC
|
K192161 |
01/22/2020
|
jkh stimulator plus
|
JKH USA, LLC
|
K191151 |
06/21/2019
|
katalyst training system
|
Katalyst Inc.
|
K190966 |
02/03/2020
|
cooltone
|
Zimmer MedizinSysteme GmbH
|
K192940 |
11/15/2019
|
hivox spopad ems sp-911, sp-921
|
Hivox Biotek Inc.
|
K192264 |
11/08/2019
|
btl 799-2l
|
BTL Industries, Inc.
|
K190456 |
07/05/2019
|
everyway otc tens/ems combination
|
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
|
K192589 |
12/19/2019
|
fitrelief tens&ems wireless device
|
Heat In A Click LLC.
|
K191938 |
08/28/2020
|
health expert electronic stimulator
|
Shenzhen OSTO Technology Company Limited
|
K190673 |
12/12/2019
|