|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
enso (model 2)
|
Hinge Health, Inc.
|
K233784 |
02/23/2024
|
pain therapy device (sm9075, sm9910, sm9067, sm9587w)
|
Chongqing Rob Linka Science and Technology Co., Ltd.
|
K233092 |
02/12/2024
|
ems/tens massager device
|
Shenzhen IMDK Medical Technology Co., Ltd.
|
K233040 |
02/12/2024
|
combo electrotherapy device (models: r-c101c, r-c101d, r-c101f, r-c101g, f100, mini-tens-comb, rc101i, tens3500)
|
Shenzhen Roundwhale Technology Co. Ltd.
|
K231423 |
01/22/2024
|
hi-dow pro touch wireless 6-12 (hd-19a)
|
Hi-Dow International, Inc.
|
K233461 |
01/19/2024
|
electronic muscle stimulator (model mp01)
|
Shenzhen Hengbosi Industrial Co., Ltd.
|
K233035 |
01/08/2024
|
ems neck massager
|
Xiamen Comfier Technology Co., Ltd
|
K233492 |
12/20/2023
|
deka lily
|
El.En. S.p.A.
|
K233470 |
12/19/2023
|
sofwave system
|
Sofwave Medical Ltd.
|
K232455 |
12/14/2023
|
manaflexx 2 (model: mf002-rx, mf002-otc)
|
ManaMed, Inc
|
K231569 |
11/03/2023
|
|