manamed.comManaFlexx 2 (model: MF002-RX, MF002-OTC)
Manamed, Inc.
MANAMED LLC
FDA Registration(s)#
| 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 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 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 |
Registered Device Listings#
| 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 |
Product Codes Associated With Registrations#
PMN#
ManaSport+
Manamed, Inc.
ManaSport
Manamed, Inc.
PlasmaWave
ManaMed, Inc.
ManaFlow
ManaMed, Inc
PlasmaFlight
ManaMed, Inc.
PlasmaFlow
MANAMED, INC
GUDID#
ManaMed Inc - This Ultrasound Coupling Gel is to be used with our ManaSport+ product or any other Ultrasound devices or non-adhesive electrodes. This allows the wave pattern to transmit through the skin into the treatment site.
2022-12-31
ManaEZ Wrist Left, Extra Large - The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply the brace.Low-profile, high-quality lace design systemThis is the Extra-Large version to accommodate patients who do not fit the one-size-fits-most orthosis.
2025-10-17
ManaEZ Wrist Left, Extra Small - The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply the brace.Low-profile, high-quality lace design systemThis is the Extra-Small version to accommodate patients who do not fit the one-size-fits-most orthosis.
2025-10-17
ManaEZ Wrist Right, Extra Large - The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply the brace.Low-profile, high-quality lace design systemThis is the Extra-Large version to accommodate patients who do not fit the one-size-fits-most orthosis.
2025-10-17
ManaEZ Wrist Right, Extra Small - The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply the brace.Low-profile, high-quality lace design systemThis is the Extra-Small version to accommodate patients who do not fit the one-size-fits-most orthosis.
2025-10-17
"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."
2025-11-25
"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."
2025-11-25
"ManaEZ Single Panel Knee Immobilizer 24""" - "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."
2025-11-25
"ManaEZ 3 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 18"", 20"", and 22"" 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."
2025-11-25
"ManaEZ 3 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 18"", 20"", and 22"" 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."
2025-11-25
"ManaEZ 3 Panel Knee Immobilizer 24""" - "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 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."
2025-11-25
"ManaEZ 3 Panel Knee Immobilizer 16""" - "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."
2025-11-25
ManaMed 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 wrist
2022-10-13
ManaMed - The ManaEZ wrist is a high quality, universal wrist brace. Patent pending single pull system makes it easier for the user to self apply the brace.Low profile, high quality lace design systemUniversal sizing
2022-06-20
ManaMed - The ManaEZ wrist is a high quality, universal wrist brace. Patent pending single pull system makes it easier for the user to self apply the brace.Low profile, high quality lace design systemUniversal sizing
2022-06-20
ManaEZ ROM Ice Short - ManaEZ ROM Ice is a quick fitting, universal, knee range of motion orthosis with compression and a flexible ice pack. The brace includes range of motion hinges to allow for flexion and extension control. A quick inflation system that can improve outcomes by managing pain and swelling. This knee brace also includes an ice pack. Removable range of motion hinges, removable ice pack, and compression bulb to fill the knee orthosis with air. Lightweight, latex free breathable material. Effortless application, universal size with hook and buckle closure. Designed for either left or right leg
2025-10-17
ManaEZ Hip Ice CureTech - ManaEZ Hip Ice is a quick fitting, universal, hip range of motion orthosis. The brace includes range of motion hinges to allow for flexion and extension control. A quick inflation system that can improve outcomes by managing pain and swelling. This hip brace also includes two high quality ice packs.Quick fittingCold compressionRange of motion hingeUniversally sized
2025-10-03
ManaEZ ROM Ice CureTech - ManaEZ ROM is a quick fitting, universal, knee range of motion orthosis. The brace includes range of motion hinges to allow for flexion and extension control. A quick inflation system that can improve outcomes by managing pain and swelling. This knee brace also includes an ice pack. Removable range of motion hinges, removable ice pack, and compression bulb to fill the knee orthosis with air. Lightweight, latex free breathable material. Effortless application, universal size with hook and buckle closure. Designed for either left or right leg
2025-10-03
ManaEZ Shoulder Ice CureTech - The ManaEZ Shoulder ice a convenient shoulder orthosis for pain, swelling, and to compress the shoulder joint.Pump up with air and compress the cold to alleviate pain faster.Removable gel liner for cooling in freezer.Drip free fabric to allow breathing.Easy to apply over clothing.Can be used for sprains, sports injuries, rehab, arthritis, and muscle tensions / fatigues.
2025-10-03
ManaEZ Ice Long Duration Knee - A long duration ice pack that can be used with our ice wraps and braces.
2025-11-25
ManaEZ Ice Long Duration Hip - A long duration ice pack that can be used with our ice wraps and braces.
2025-11-25
ManaEZ Ice Long Duration Ankle - A long duration ice pack that can be used with our ice wraps and braces.
2025-11-25
ManaEZ Ice Long Duration Shoulder - A long duration ice pack that can be used with our ice wraps and braces.
2025-11-25
ManaEZ Ice Long Duration Back - A long duration ice pack that can be used with our ice wraps and braces.
2025-11-25
Cold Compression Wrap, Pro-Ankle Wrap - Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack.Features: -2 pneumatic ports to treat 1 or 2 areas at one time-Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema-LCD screen displays pressure to show inflation cycle-Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes-Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing
2025-09-26
Cold Compression Wrap, Pro-Back Wrap - Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack.Features: -2 pneumatic ports to treat 1 or 2 areas at one time-Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema-LCD screen displays pressure to show inflation cycle-Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes-Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing
2025-09-26
Cold Compression Wrap, Pro-Elbow Wrap - Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack.Features: -2 pneumatic ports to treat 1 or 2 areas at one time-Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema-LCD screen displays pressure to show inflation cycle-Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes-Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing
2025-09-26
Cold Compression Wrap, Pro-Hip Wrap - Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack.Features: -2 pneumatic ports to treat 1 or 2 areas at one time-Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema-LCD screen displays pressure to show inflation cycle-Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes-Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing
2025-09-26
Cold Compression Wrap, Pro-Knee Wrap - Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack.Features: -2 pneumatic ports to treat 1 or 2 areas at one time-Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema-LCD screen displays pressure to show inflation cycle-Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes-Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing
2025-09-26
Cold Compression Wrap, Pro-Shoulder Wrap - Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack.Features: -2 pneumatic ports to treat 1 or 2 areas at one time-Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema-LCD screen displays pressure to show inflation cycle-Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes-Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing
2025-09-26
Cold Compression Wrap, Pro-Ankle Wrap-WL - Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack.Features: -2 pneumatic ports to treat 1 or 2 areas at one time-Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema-LCD screen displays pressure to show inflation cycle-Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes-Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing
2025-09-26
Cold Compression Wrap, Pro-Shoulder Wrap-WL - Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack.Features: -2 pneumatic ports to treat 1 or 2 areas at one time-Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema-LCD screen displays pressure to show inflation cycle-Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes-Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing
2025-09-26
Cold Compression Wrap, Pro-Knee Wrap-WL - Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack.Features: -2 pneumatic ports to treat 1 or 2 areas at one time-Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema-LCD screen displays pressure to show inflation cycle-Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes-Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing
2025-09-26
Cold Compression Wrap, Pro-Hip Wrap-WL - Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack.Features: -2 pneumatic ports to treat 1 or 2 areas at one time-Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema-LCD screen displays pressure to show inflation cycle-Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes-Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing
2025-09-26
Cold Compression Wrap, Pro-Back Wrap-WL - Pneumatic compression pump that attaches to one of our six compression wraps for elbow, hip, knee, shoulder, back, and ankle. Pump comes with a battery, screwdriver to insert the battery, and a charger. The compression wrap attachments are sold separately and have one removable cryo-gel pack.Features: -2 pneumatic ports to treat 1 or 2 areas at one time-Adjustable pressure settings: 20, 40, 60, 80, or 100 mmHg to control edema-LCD screen displays pressure to show inflation cycle-Set treatment times - 10-minute intervals up to 120 minutes with default of 30 minutes-Has a rechargeable battery for portability or use while charging -Easy-to-clean nylon material -Simple strapping system for donning & doffing
2025-09-26
ManaMed - The ManaEZ Hinged Ice is a convenient wrap-on hinged sleeve with a section for ice. The open popliteal feature allows for a comfortable fit.Wrap feature for easy on and off applicationHigh quality neopreneOpen poplitealIce compartment for reducing inflammation
2022-08-25
ManaMed - Quick ankle wrap orthosis design with a removeable ice pack. A quick inflation system that can improve outcomes by managing pain and swelling.Universally sized, removable ice pack, compression bulb, quick wrap design
2022-06-21
ManaMed - ManaEZ ROM is a quick fitting, universal, knee range of motion orthosis. The brace includes range of motion hinges to allow for flexion and extension control. A quick inflation system that can improve outcomes by managing pain and swelling. This knee brace also includes an ice pack. Removable range of motion hinges, removable ice pack, and compression bulb to fill the knee orthosis with air. Lightweight, latex free breathable material. Effortless application, universal size with hook and buckle closure. Designed for either left or right leg
2022-06-21
ManaMed - The ManaEZ Shoulder ice a convenient shoulder orthosis for pain, swelling, and to compress the shoulder joint.Pump up with air and compress the cold to alleviate pain faster.Removable gel liner for cooling in freezer.Drip free fabric to allow breathing.Easy to apply over clothing.Can be used for sprains, sports injuries, rehab, arthritis, and muscle tensions / fatigues.
2022-06-21
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.
2025-11-25