| Primary Device ID | 00810113681818 | 
| NIH Device Record Key | 646bddde-c451-4d39-8c6d-583a1913cd76 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | ManaMed | 
| Version Model Number | ManaEZ Boot Air Short Large | 
| Catalog Number | SEZBA01L | 
| Company DUNS | 084042331 | 
| Company Name | MANAMED INC | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | false | 
| OTC Over-The-Counter | true | 
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | |
| Phone | 888-508-0712 | 
| support@manamed.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00810113681818 [Primary] | 
| ITW | Joint, Ankle, External Brace | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-06-28 | 
| Device Publish Date | 2022-06-20 | 
| 00810113680811 | The gOAt is a universally sized, low-profile, lightweight option for patients with moderate knee | 
| 00810113680804 | The gOAt is a universally sized, low-profile, lightweight option for patients with moderate knee | 
| 00810113680514 | The ManaEZ Hinged Knee is a convenient wrap on hinged sleeve. The open popliteal feature allows | 
| 00810113681597 | The Mini Kahuna Brace is universal and can be applied to right or left side. The breathable mate | 
| 00810113680590 | ManaEZ Ice Wrap Knee is a quick fitting, universal, knee range of motion orthosis. This knee bra | 
| 00850998008980 | ManaCold Water Circulating Therapy Device is used decrease pain, swelling, and muscle spasms aft | 
| 00850998008966 | The Royal Boot Air Short is a pneumatic walker boot built with a unique rocker bottom to simulat | 
| 00850998008959 | The Royal Boot Air Short is a pneumatic walker boot built with a unique rocker bottom to simulat | 
| 00850998008942 | The Royal Boot Air Short is a pneumatic walker boot built with a unique rocker bottom to simulat | 
| 00850998008935 | The Royal Boot Air Short is a pneumatic walker boot built with a unique rocker bottom to simulat | 
| 00850998008928 | The Royal Boot Air Short is a pneumatic walker boot built with a unique rocker bottom to simulat | 
| 00850998008898 | The ManaFlow is a four-chamber tubeless pneumatic compression device used to treat lymphedema or | 
| 00850998008836 | Halfback50 Lumbar-Sacral Orthosis (LSO) is designed to provide support for spinal injuries and c | 
| 00850998008256 | The Royal Boot is a tall pneumatic walker boot built with a unique rocker bottom to simulate nat | 
| 00850998008249 | The Royal Boot is a tall pneumatic walker boot built with a unique rocker bottom to simulate nat | 
| 00850998008232 | The Royal Boot is a tall pneumatic walker boot built with a unique rocker bottom to simulate nat | 
| 00850998008225 | The Royal Boot is a tall pneumatic walker boot built with a unique rocker bottom to simulate nat | 
| 00850998008218 | The Royal Boot is a tall pneumatic walker boot built with a unique rocker bottom to simulate nat | 
| 00850998008201 | The ManaEZ Boot Air is a tall pneumatic walker boot built with a unique rocker bottom to simulat | 
| 00850998008188 | The ManaEZ Thumb Spica is a universal orthosis that includes our patent pending pull system. Low | 
| 00850998008171 | The ManaEZ Thumb Spica is a universal orthosis that includes our patent pending pull system. Low | 
| 00850998008164 | The ManaEZ Boot Air is a tall pneumatic walker boot built with a unique rocker bottom to simulat | 
| 00850998008157 | The ManaEZ Boot Air is a tall pneumatic walker boot built with a unique rocker bottom to simulat | 
| 00850998008140 | The ManaEZ Boot Air is a tall pneumatic walker boot built with a unique rocker bottom to simulat | 
| 00850998008133 | The ManaEZ Boot Air is a tall pneumatic walker boot built with a unique rocker bottom to simulat | 
| 00850998008126 | The ManaEZ wrist is a high quality, universal wrist brace. Patent pending single pull system mak | 
| 00850998008119 | The ManaEZ wrist is a high quality, universal wrist brace. Patent pending single pull system mak | 
| 00810113682396 | The ManaSport provides non-invasive therapy of low-intensity pulsed ultrasound for the treatment | 
| 00810113682259 | The ManaFlow is a four-chamber tubeless pneumatic compression device used to treat lymphedema or | 
| 00810113681931 | The Tailback 64 is a universal spinal orthosis designed with our patent pending chord compressio | 
| 00810113681924 | The Tailback 56 is a universal spinal orthosis designed with our patent pending chord compressio | 
| 00810113681900 | The Tailback 50 is a universal spinal orthosis designed with our patent pending chord compressio | 
| 00810113681894 | The Tailback 48 is a universal spinal orthosis designed with our patent pending chord compressio | 
| 00810113681887 | The Tailback 42 is a universal spinal orthosis designed with our patent pending chord compressio | 
| 00810113681856 | The ManaEZ Boot Air Short is a pneumatic walker boot built with a unique rocker bottom to simula | 
| 00810113681849 | The ManaEZ Boot Air Short is a pneumatic walker boot built with a unique rocker bottom to simula | 
| 00810113681832 | The ManaEZ Boot Air Short is a pneumatic walker boot built with a unique rocker bottom to simula | 
| 00810113681825 | The ManaEZ Boot Air Short is a pneumatic walker boot built with a unique rocker bottom to simula | 
| 00810113681818 | The ManaEZ Boot Air Short is a pneumatic walker boot built with a unique rocker bottom to simula | 
| 00810113681641 | The Nature’s Bond Breast Pump is a personal use electric breast pump with a battery powered op | 
| 00810113681634 | The ManaWater Sling is a waterproof arm sling that is designed to be worn in the shower, bath, o | 
| 00810113681511 | The ManaFlow is a four-chamber tubeless pneumatic compression device used to treat lymphedema or | 
| 00810113680880 | The Kangaroo Sling is universal and can be applied to right or left side. The breathable materia | 
| 00810113680859 | The Kahuna Brace provides support for shoulder surgeries in a universal multiple configuration b | 
| 00810113680767 | The ManaEZ Tendon Strap Universal is used to soothe tennis elbow pain. Low profile, neoprene str | 
| 00810113680743 | Our spring crutch is lightweight and comfortable; comes in pairs. Universal sizing Height adjust | 
| 00810113680736 | The EZ Sling Universal shoulder immobilizer includes a waist strap. For use with the treatment o | 
| 00810113680729 | The ManaEZ sling is a convenient, comfortable, and simple way to immobilize the shoulder and elb | 
| 00810113680712 | The ManaEZ sling is a convenient, comfortable, and simple way to immobilize the shoulder and elb | 
| 00810113680705 | The ManaEZ sling is a convenient, comfortable, and simple way to immobilize the shoulder and elb | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  MANAMED  86937013  5266920 Live/Registered | ManaMed, Inc. 2016-03-11 | 
|  MANAMED  86615982  4873623 Live/Registered | ManaMed Inc. 2015-04-30 |