ManaMed EZANKLE01
GUDID 00810113680323
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
MANAMED INC
Hot/cold therapy pack, reusable| Primary Device ID | 00810113680323 |
| NIH Device Record Key | 01e74f14-ff9a-4793-a107-f7155bd627e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ManaMed |
| Version Model Number | ManaEZ Ankle Ice |
| Catalog Number | EZANKLE01 |
| 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 | |
| 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 | 00810113680323 [Primary] |
FDA Product Code
| KYR | Bag, Ice |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.