Manamed, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Manamed, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ManaFlexx 2 (model: MF002-RX, MF002-OTC), ManaSport+, ManaSport
7
Total
7
Cleared
0
Denied
Manamed, Inc. has 7 FDA 510(k) cleared medical devices. Based in Costa Mesa, US.
Last cleared in 2023. Active since 2016. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Manamed, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Jkh USA, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Manamed, Inc.
7 devices
Cleared
Nov 03, 2023
ManaFlexx 2 (model: MF002-RX, MF002-OTC)
Neurology
156d
Cleared
Mar 08, 2023
ManaSport+
Physical Medicine
233d
Cleared
Apr 26, 2022
ManaSport
Physical Medicine
448d
Cleared
May 26, 2021
PlasmaWave
Cardiovascular
30d
Cleared
Aug 06, 2020
ManaFlow
Cardiovascular
175d
Cleared
Aug 05, 2020
PlasmaFlight
Physical Medicine
175d
Cleared
Apr 01, 2016
PlasmaFlow
Cardiovascular
56d