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MANAMED LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30117677243011767724MANAMED LLC1Y2026-01-012612 Sirius Drive Denton TX US 76208

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1855192060556154K251446PlasmaFlow X Compression Sleeve Device (XPF0001)JOW2025-09-17
1855191517043331K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)NUH2023-11-03
1855191460912135K222098ManaSport+IMI2023-03-08
1855191557008460K221999Ultrasound Transmission GelsMUI2022-08-30
1855191533067938K211253PlasmaWaveJOW2021-05-26
1855191023282952K200353ManaFlowJOW2020-08-06
1855191240000278K200351PlasmaFlightIRP2020-08-05
1855191768259441K160318PlasmaFlowJOW2016-04-01
1855191675839172K131921ELECTRONIC PULSE STIMULATORNUH2013-11-15
1855191547725359K130691ELECTROTHERAPY DEVICE (COMBO UNIT)IPF2013-12-20
1855191522613177K121719SM TENS & PMSNGX2013-05-10
1855191912062978K113544ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGERGZJ2012-07-27
1855191222635744
1855191229019998
1855191612310382
1855191892010289
1855192040470901
1855191092119476
1855191210013126
1855191238281291
1855191247569865
1855191296967490
1855191474836472
1855191479745018
1855191530103439
1855191579159650
1855191603788898
1855191741827627
1855191847594140
1855191909603944
1855191949942988
1855191960814231
1855192029899721

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JOW42025-09-17
NUH22023-11-03
IMI12023-03-08
MUI12022-08-30
IRP12020-08-05
IPF12013-12-20
NGX12013-05-10
GZJ12012-07-27