MANAMED LLC

Matched from indexed company URL: MANAMED INC

FDA Registration(s)#

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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810113682600ManaMed Inc - ManaEZ Ice Wrist is a quick fitting, universal, wrist orthosis. This wrist brace also includes an ice pack.Removable ice packLightweight, latex free breathable materialEffortless application, universal size with hook and loop closureDesigned for either left or right wrist888-508-0712support@manamed.com

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

PMN#

GUDID#

200 records. Showing 1-40. Next