ManaMed EZRE001
GUDID 00810113680644
The ManaEZ Rom Elite adjustable knee brace allows the user to adjust the length of the brace for custom fitting. This product is ideal for knee ligament damage, knee surgeries, and instability of the knee. The ManaEZ Rom Elite is designed for post-operative fixation, allowing the doctor to lock the patient into extension and control range of motion as prescribed. ManaEZ ROM Elite is a quick fitting, universal, telescoping, and drop lock post op knee brace. The brace has a unique malleable bar system to conform to all shapes and sizes. -Telescoping and malleable hinge bars extendable from 16.5" - 27" (42cm - 68.5cm) -Hinge range of motion adjustment: Flexion (0° - 120°) and extension (0° - 90°) -Quick lock key offers ability to control and lock out the hinge motion to 0°, 15°, and 30° directly -Lightweight, latex free breathable material -Easy application, universal size with hook and buckle closure, design fits either leg
MANAMED INC
Knee orthosis Knee orthosis Knee orthosis Knee orthosis Knee orthosis Knee orthosis Knee orthosis Knee orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis Knee support orthosis| Primary Device ID | 00810113680644 |
| NIH Device Record Key | 54794dbd-96ad-4e37-a882-aa89559a6024 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ManaMed |
| Version Model Number | ManaEZ ROM Elite |
| Catalog Number | EZRE001 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810113680644 [Primary] |
FDA Product Code
| ITQ | Joint, Knee, External Brace |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-29 |
| Device Publish Date | 2022-06-21 |
On-Brand Devices [ManaMed]
| 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 |
Trademark Results [ManaMed]
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 |
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