|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
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
|
low-frequency multi-function physiotherapy instrument (model: ktr-2230, ktr-2220, ktr-2210, ktr-2231, ktr-2221, ktr-2211, ktr-2232, ktr-2222, ktr-2212)
|
Shenzhen Kentro Medical Electronics Co., Ltd
|
K191982 |
09/25/2020
|
msls6qf tens/pms device
|
Self Doctor Care, LLC
|
K193655 |
09/04/2020
|
sunmas tens & pms (model sm9187, sm9180l, sm9180s)
|
Hong Qiangxing (Shen Zhen) Electronics Limited
|
K190009 |
12/02/2019
|
hivox otc electrical stimulator
|
Hivox Biotek Inc.
|
K190347 |
03/15/2019
|