FDA.reportPublic FDA data

Mana

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30117677243011767724MANAMED LLC1Y2026-01-012612 Sirius Drive Denton TX US 76208
96808263007381745Manali Patel1N2020-04-25225 Reinekers Lane Suite 300 Alexandria VA US 22314

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810113682600ManaMed 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 wrist888-508-0712support@manamed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1855192060556154K251446PlasmaFlow X Compression Sleeve Device (XPF0001)JOW2025-09-17
1855191517043331K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)NUH2023-11-03
1855191460912135K222098ManaSport+IMI2023-03-08
1855191557008460K221999Ultrasound Transmission GelsMUI2022-08-30
1855191533067938K211253PlasmaWaveJOW2021-05-26
1855191023282952K200353ManaFlowJOW2020-08-06
1855191240000278K200351PlasmaFlightIRP2020-08-05
1855191768259441K160318PlasmaFlowJOW2016-04-01
1855191675839172K131921ELECTRONIC PULSE STIMULATORNUH2013-11-15
1855191547725359K130691ELECTROTHERAPY DEVICE (COMBO UNIT)IPF2013-12-20
1855191522613177K121719SM TENS & PMSNGX2013-05-10
1855191912062978K113544ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGERGZJ2012-07-27
1855191222635744
1855191229019998
831111474551928
1855191612310382
831111639214396
1855191892010289
1855192040470901
1855191092119476
1855191210013126
1855191238281291
1855191247569865
1855191296967490
1855191474836472
1855191479745018
1855191530103439
1855191579159650
1855191603788898
1855191741827627
1855191847594140
1855191909603944
1855191949942988
1855191960814231
1855192029899721

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JOW42025-09-17
NUH22023-11-03
IMI12023-03-08
MUI12022-08-30
IRP12020-08-05
IPF12013-12-20
NGX12013-05-10
GZJ12012-07-27

NDC#

PMN#

66 records. Showing 1-40. Next

GUDID#

"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."

Manamed, Inc.

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."

Manamed, Inc.

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."

Manamed, Inc.

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."

Manamed, Inc.

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."

Manamed, Inc.

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."

Manamed, Inc.

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."

Manamed, Inc.

2025-11-25

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

Manamed, Inc.

2022-06-21

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

Manamed, Inc.

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

Manamed, Inc.

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

Manamed, Inc.

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

Manamed, Inc.

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

Manamed, Inc.

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

Manamed, Inc.

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

Manamed, Inc.

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

Manamed, Inc.

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

Manamed, Inc.

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

Manamed, Inc.

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

Manamed, Inc.

2025-09-26

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

Manamed, Inc.

2025-10-03

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

Manamed, Inc.

2025-10-17

80 records. Showing 1-40. Next