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Manamed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251446PlasmaFlow X Compression Sleeve Device (XPF0001)September 17, 2025
K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)November 3, 2023
K222098ManaSport+March 8, 2023
K210284ManaSportApril 26, 2022
K211253PlasmaWaveMay 26, 2021
K200353ManaFlowAugust 6, 2020
K200351PlasmaFlightAugust 5, 2020
K160318PlasmaFlowApril 1, 2016