|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
sofwave system
|
Sofwave Medical Ltd.
|
K232455 |
12/14/2023
|
tens and ems stimulation (otc)
|
Changsha Yuwen Medical Equipment Co., Ltd
|
K230163 |
03/20/2023
|
body contouring machine (models: cs2, cs3, cs5, cs7, cs8, cs11, cs13)
|
Hebei JT Medical Co., Ltd.
|
K232181 |
04/24/2024
|
electromagnetic stimulator device(model em contouring and tesla duet)
|
Beijing ADSS Development Co., Ltd.
|
K231318 |
07/07/2023
|
enso (model 2)
|
Hinge Health, Inc.
|
K233784 |
02/23/2024
|
manaflexx 2 (model: mf002-rx, mf002-otc)
|
ManaMed, Inc
|
K231569 |
11/03/2023
|
muscle stimulator
|
Shenzhen Yiran Intelligent Co., Ltd
|
K231648 |
03/01/2024
|
tens and ems stimulation (otc)
|
Changsha Yuwen Medical Equipment Co., Ltd
|
K230164 |
04/10/2023
|
hi-dow pro touch wireless 6-12 (hd-19a)
|
Hi-Dow International, Inc.
|
K233461 |
01/19/2024
|
pain therapy device (model: p.t.s-vi, p.t.s-vii)
|
Guangzhou Xinbo Electronic Co., Ltd.
|
K231789 |
03/11/2024
|