|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
hbotc muscle and nerve stimulator
|
HB MEDICAL, INC.
|
K160255 |
09/15/2016
|
flowkeepers
|
DK ELECTRONICS, LLC
|
K160323 |
04/06/2017
|
katalyst mark 1 muscle stimulation system
|
Katalyst Inc.
|
K171035 |
09/06/2017
|
mytens model: bw-tsx
|
Bewell Connect Corp.
|
K171026 |
11/01/2017
|
dual output digital therapy massager
|
Shenzhen OSTO Technology Co., Ltd.
|
K172834 |
09/06/2018
|
otc combo tens/ems system
|
Well-Life Healthcare Limited
|
K172809 |
10/18/2017
|
powerdot pd-01m
|
Smartmissimo Technologies Pte Ltd
|
K172876 |
12/04/2017
|
dr.music 3s
|
SmartMedicalDevice Co., Ltd.
|
K172451 |
11/17/2017
|
iq technologies
|
IQ Technologies Inc.
|
K170659 |
05/26/2017
|
hivox otc electrical stimulator
|
Hivox Biotek Inc.
|
K171803 |
11/29/2017
|