Skip to the page
Get started – free

Data / Medical devices / United States / Manamed LLC

Manamed LLC: FDA-registered device maker in Denton, TX, United States, 8 510(k) clearances

Manamed LLC is registered with the FDA (registration 3011767724) in Denton, TX, United States. It lists 26 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 17, 2025. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Manamed LLC
FDA registration number
3011767724
Address
2612 Sirius Drive, Denton, TX, United States, 76208
Owner or operator
ManaMed LLC (10049811)
Roles
Complaint file establishment, Repackager or relabeler, Specification developer
First device listed
August 3, 2015
Registered through
2027
Brand names listed
Belly Band, ManaEZ Crutch Spring, ManaEZ sling Universal, ManaGo 71, PlasmaFlight, PlasmaFlow

Devices it lists

DeviceProduct codeClassRoleSource
Band Or Belt, Pelvic SupportISR1Complaint file establishmentaccessdata.fda.gov
Bandage, ElasticFQM1Specification developeraccessdata.fda.gov
CrutchIPR1Specification developeraccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Specification developeraccessdata.fda.gov
Joint, Ankle, External BraceITW1Complaint file establishment, Specification developeraccessdata.fda.gov
Joint, Hip, External BraceITS1Specification developeraccessdata.fda.gov
Joint, Knee, External BraceITQ1Complaint file establishment, Specification developeraccessdata.fda.gov
Massager, Powered Inflatable TubeIRP2Specification developeraccessdata.fda.gov
Media, Coupling, UltrasoundMUI2Complaint file establishmentaccessdata.fda.gov
Orthosis, CervicalIQK1Specification developeraccessdata.fda.gov
Orthosis, Limb BraceIQI1Complaint file establishmentaccessdata.fda.gov
Orthosis, LumbarIQE1Specification developeraccessdata.fda.gov
Orthosis, Lumbo-SacralIPY1Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthosis, ThoracicIPT1Specification developeraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Complaint file establishmentaccessdata.fda.gov
Pack, Hot Or Cold, Water CirculatingILO2Complaint file establishmentaccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Specification developeraccessdata.fda.gov
Sling, ArmILI1Specification developeraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Specification developeraccessdata.fda.gov
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep HeatPFW2Specification developeraccessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For ArthritisNYN2Specification developeraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Specification developeraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Specification developeraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Specification developeraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Specification developeraccessdata.fda.gov
Ultrasonic Diathermy For Use In Applying Therapeutic Deep HeatIMI2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 17, 2025K251446PlasmaFlow X Compression Sleeve Device (XPF0001)JOWSubstantially EquivalentManamed, LLCaccessdata.fda.gov
November 3, 2023K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)NUHSubstantially EquivalentManamed, Inc.accessdata.fda.gov
March 8, 2023K222098ManaSport+IMISubstantially EquivalentManamed, Inc.accessdata.fda.gov
August 30, 2022K221999Ultrasound Transmission GelsMUISubstantially EquivalentHony Medical Co., Ltd.accessdata.fda.gov
May 26, 2021K211253PlasmaWaveJOWSubstantially EquivalentManamed, Inc.accessdata.fda.gov
August 6, 2020K200353ManaFlowJOWSubstantially EquivalentManamed, Inc.accessdata.fda.gov
August 5, 2020K200351PlasmaFlightIRPSubstantially EquivalentManamed, Inc.accessdata.fda.gov
April 1, 2016K160318PlasmaFlowJOWSubstantially EquivalentManamed, Inc.accessdata.fda.gov

Compare with other makers

Updated September 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.