ManaFlexx 2 (model: MF002-RX, MF002-OTC)
Manamed, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011767724 | 3011767724 | MANAMED LLC | 1 | Y | 2026-01-01 | 2612 Sirius Drive Denton TX US 76208 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810113682730 | ManaSlide - ManaSlide is a patient transfer blanket designed to assist in patient positioning in a bed or for moving a patient from a bed to another. | 888-508-0712 | support@manamed.com |
| 00810113682969 | "ManaEZ Single Panel Knee Immobilizer 18""" - "The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The combination of the posterior stay and two adjustable lateral stays maintains the optimum leg position. The popliteal pad ensures an intimate fit around the knee joint. Available in 16"", 18"", 20"", and 24"" lengths in our single and three-panel design. Ideal for strains and sprains of the knee, stable fractures of the tibia, and patellar tendon repairs." | 888-508-0712 | support@manamed.com |
| 00810113682976 | "ManaEZ Single Panel Knee Immobilizer 20""" - "The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The combination of the posterior stay and two adjustable lateral stays maintains the optimum leg position. The popliteal pad ensures an intimate fit around the knee joint. Available in 16"", 18"", 20"", and 24"" lengths in our single and three-panel design. Ideal for strains and sprains of the knee, stable fractures of the tibia, and patellar tendon repairs." | 888-508-0712 | support@manamed.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 185519 | 2060556154 | K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) | JOW | 2025-09-17 |
| 185519 | 1517043331 | K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | NUH | 2023-11-03 |
| 185519 | 1460912135 | K222098 | ManaSport+ | IMI | 2023-03-08 |
| 185519 | 1557008460 | K221999 | Ultrasound Transmission Gels | MUI | 2022-08-30 |
| 185519 | 1533067938 | K211253 | PlasmaWave | JOW | 2021-05-26 |
| 185519 | 1023282952 | K200353 | ManaFlow | JOW | 2020-08-06 |
| 185519 | 1240000278 | K200351 | PlasmaFlight | IRP | 2020-08-05 |
| 185519 | 1768259441 | K160318 | PlasmaFlow | JOW | 2016-04-01 |
| 185519 | 1675839172 | K131921 | ELECTRONIC PULSE STIMULATOR | NUH | 2013-11-15 |
| 185519 | 1547725359 | K130691 | ELECTROTHERAPY DEVICE (COMBO UNIT) | IPF | 2013-12-20 |
| 185519 | 1522613177 | K121719 | SM TENS & PMS | NGX | 2013-05-10 |
| 185519 | 1912062978 | K113544 | ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER | GZJ | 2012-07-27 |
| 185519 | 1222635744 | ||||
| 185519 | 1229019998 | ||||
| 185519 | 1612310382 | ||||
| 185519 | 1892010289 | ||||
| 185519 | 2040470901 | ||||
| 185519 | 1092119476 | ||||
| 185519 | 1210013126 | ||||
| 185519 | 1238281291 | ||||
| 185519 | 1247569865 | ||||
| 185519 | 1296967490 | ||||
| 185519 | 1474836472 | ||||
| 185519 | 1479745018 | ||||
| 185519 | 1530103439 | ||||
| 185519 | 1579159650 | ||||
| 185519 | 1603788898 | ||||
| 185519 | 1741827627 | ||||
| 185519 | 1847594140 | ||||
| 185519 | 1909603944 | ||||
| 185519 | 1949942988 | ||||
| 185519 | 1960814231 | ||||
| 185519 | 2029899721 |
Manamed, Inc.
Manamed, Inc.
Manamed, Inc.
ManaMed, Inc.
ManaMed, Inc
ManaMed, Inc.
MANAMED, INC
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