curetechusa.com
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 | |
|---|---|---|---|
| 00810113683065 | 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 | 888-508-0712 | support@manamed.com |
| 00810113683515 | 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 fitting Cold compression Range of motion hinge Universally sized | 866-284-8872 | sales@curetechusa.com |
| 00810113683522 | 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 | 866-284-8872 | sales@curetechusa.com |
| 00810113683539 | 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. | 866-284-8872 | sales@curetechusa.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
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 system This 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 system This 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 system This 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 system This is the Extra-Small version to accommodate patients who do not fit the one-size-fits-most orthosis.
2025-10-17
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 fitting Cold compression Range of motion hinge Universally 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
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
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
Extension Panel - Zynex Pro Hybrid LSO 637 - The Zynex Pro Hybrid LSO 637 is a universal sacral-lubmar orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a rigid, comfortable, and quick fitting solution for every patient. This device is the extension panel to increase the size of the brace.
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
Three in One Belly Band - Wrap the belt around your belly while making sure the pad is centered and placed under your abdomen for comfort and support. Hand wash in cold water with mild detergent Air dry
2025-11-25
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
ManaEZ Ankle 06 Extra Small - The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes from heel to midfoot. Two uprights create a stirrup with a hinge for uninhibited ankle motion.
2025-09-26
ManaEZ Ankle 06 Small - The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes from heel to midfoot. Two uprights create a stirrup with a hinge for uninhibited ankle motion.
2025-09-26
ManaEZ Ankle 06 Medium - The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes from heel to midfoot. Two uprights create a stirrup with a hinge for uninhibited ankle motion.
2025-09-26
ManaEZ Ankle 06 Large - The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes from heel to midfoot. Two uprights create a stirrup with a hinge for uninhibited ankle motion.
2025-09-26
ManaEZ Ankle 06 Extra Large - The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes from heel to midfoot. Two uprights create a stirrup with a hinge for uninhibited ankle motion.
2025-09-26
ManaEZ Ankle 06 Extra Extra Large - The ManaEZ Ankle 06 is a low-profile multiligamentous brace with a plastic hinge assembly consisting of a footplate that goes from heel to midfoot. Two uprights create a stirrup with a hinge for uninhibited ankle motion.
2025-09-26
ManaEZ Night Splint, Plantar Fasciitis, Small - Ideal for patients that need to stretch the Achilles Tendon or Plantar Fascia. Common indications are Plantar Fasciitis, Tight Achilles, Achilles Tendonitis, and conditions where dorsiflexing the foot is part of the rehabilitation protocol. Easy-to-apply universal left/right design available in 3 sizes.
2025-09-26
ManaEZ Night Splint, Plantar Fasciitis, Medium - Ideal for patients that need to stretch the Achilles Tendon or Plantar Fascia. Common indications are Plantar Fasciitis, Tight Achilles, Achilles Tendonitis, and conditions where dorsiflexing the foot is part of the rehabilitation protocol. Easy-to-apply universal left/right design available in 3 sizes.
2025-09-26
ManaEZ Night Splint, Plantar Fasciitis, Large - Ideal for patients that need to stretch the Achilles Tendon or Plantar Fascia. Common indications are Plantar Fasciitis, Tight Achilles, Achilles Tendonitis, and conditions where dorsiflexing the foot is part of the rehabilitation protocol. Easy-to-apply universal left/right design available in 3 sizes.
2025-09-26
ManoFX Left - The ManoFX is a wrist hand finger orthosis. The unique design allows fractures of the hand and finger to be positioned for optimum healing. This innovative approach allows customization of the brace to be configured as a Boxer's fracture splint (ulnar gutter splint), Radial Gutter splint, or a Buddy finger splint (metacarpal fracture brace). Features: Malleable aluminum stays Split dorsal stay Soft breathable body Wraparound design for customized fit
2025-09-26
ManoFX Right - The ManoFX is a wrist hand finger orthosis. The unique design allows fractures of the hand and finger to be positioned for optimum healing. This innovative approach allows customization of the brace to be configured as a Boxer's fracture splint (ulnar gutter splint), Radial Gutter splint, or a Buddy finger splint (metacarpal fracture brace). Features: Malleable aluminum stays Split dorsal stay Soft breathable body Wraparound design for customized fit
2025-09-26
ManaGO71 Ankle Brace Extra Large - The ManaGO 71 provides three different levels of support in one brace. The unique design allows components to be removed as the patient's condition improves. In its extended gauntlet configuration, the ManaGO 71 provides maximum protection for ankle sprains and Syndesmosis injuries. The gauntlet and hinge stirrup with footplate captures the entire ankle mechanism. Removable upper cuff and hinge stirrup with footplate can be removed as recovery improves. Features: Speed lacing ankle foot brace that extends to boot height on the calf Interlocking plastic plates and hinge assembly Figure-eight strapping
2025-09-26
ManaGO71 Ankle Brace Large - The ManaGO 71 provides three different levels of support in one brace. The unique design allows components to be removed as the patient's condition improves. In its extended gauntlet configuration, the ManaGO 71 provides maximum protection for ankle sprains and Syndesmosis injuries. The gauntlet and hinge stirrup with footplate captures the entire ankle mechanism. Removable upper cuff and hinge stirrup with footplate can be removed as recovery improves. Features: Speed lacing ankle foot brace that extends to boot height on the calf Interlocking plastic plates and hinge assembly Figure-eight strapping
2025-09-26
ManaGO71 Ankle Brace Medium - The ManaGO 71 provides three different levels of support in one brace. The unique design allows components to be removed as the patient's condition improves. In its extended gauntlet configuration, the ManaGO 71 provides maximum protection for ankle sprains and Syndesmosis injuries. The gauntlet and hinge stirrup with footplate captures the entire ankle mechanism. Removable upper cuff and hinge stirrup with footplate can be removed as recovery improves. Features: Speed lacing ankle foot brace that extends to boot height on the calf Interlocking plastic plates and hinge assembly Figure-eight strapping
2025-09-26
ManaGO71 Ankle Brace Small - The ManaGO 71 provides three different levels of support in one brace. The unique design allows components to be removed as the patient's condition improves. In its extended gauntlet configuration, the ManaGO 71 provides maximum protection for ankle sprains and Syndesmosis injuries. The gauntlet and hinge stirrup with footplate captures the entire ankle mechanism. Removable upper cuff and hinge stirrup with footplate can be removed as recovery improves. Features: Speed lacing ankle foot brace that extends to boot height on the calf Interlocking plastic plates and hinge assembly Figure-eight strapping
2025-09-26
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