Total clearances
8
2020-08-05 → 2026-08-12
Name variants in FDA filings: Manamed, LLC / Manamed, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| JOW |
Sleeve, Limb, Compressible |
Class II |
Cardiovascular |
3 |
2025-09-17 |
| IRP |
— |
— |
— |
2 |
2026-08-12 |
| IMI |
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
Class II |
Physical Medicine |
2 |
2023-03-08 |
| NUH |
Stimulator, Nerve, Transcutaneous, Over-The-Counter |
Class II |
Neurology |
1 |
2023-11-03 |
Filings
All 510(k) clearances (8)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-08-12 |
K260944 |
ManaCold Compression System |
IRP |
— |
— |
| 2025-09-17 |
K251446 |
PlasmaFlow X Compression Sleeve Device (XPF0001) |
JOW |
Class II |
Cardiovascular |
| 2023-11-03 |
K231569 |
ManaFlexx 2 (model: MF002-RX, MF002-OTC) |
NUH |
Class II |
Neurology |
| 2023-03-08 |
K222098 |
ManaSport+ |
IMI |
Class II |
Physical Medicine |
| 2022-04-26 |
K210284 |
ManaSport |
IMI |
Class II |
Physical Medicine |
| 2021-05-26 |
K211253 |
PlasmaWave |
JOW |
Class II |
Cardiovascular |
| 2020-08-06 |
K200353 |
ManaFlow |
JOW |
Class II |
Cardiovascular |
| 2020-08-05 |
K200351 |
PlasmaFlight |
IRP |
— |
— |