ManaEZ ROM Ice CureTech EZR001-CT

GUDID 00810113683522

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.

Knee support orthosis
Primary Device ID00810113683522
NIH Device Record Keyad0fda97-ec04-4174-94e2-b014032aa291
Commercial Distribution StatusIn Commercial Distribution
Brand NameManaEZ ROM Ice CureTech
Version Model NumberEZR001-CT
Catalog NumberEZR001-CT
Company DUNS084042331
Company NameManamed, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com
Phone866-284-8872
Emailsales@curetechusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810113683522 [Primary]

FDA Product Code

ITQJoint, Knee, External Brace

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-01-12
Device Publish Date2025-10-03

Devices Manufactured by Manamed, Inc.

00810113683065 - ManaEZ ROM Ice Short2026-01-12 ManaEZ ROM Ice is a quick fitting, universal, knee range of motion orthosis with compression and a flexible ice pack. The brace
00810113683515 - ManaEZ Hip Ice CureTech2026-01-12 ManaEZ Hip Ice is a quick fitting, universal, hip range of motion orthosis. The brace includes range of motion hinges to allow f
00810113683522 - ManaEZ ROM Ice CureTech2026-01-12ManaEZ 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
00810113683522 - ManaEZ ROM Ice CureTech2026-01-12 ManaEZ ROM is a quick fitting, universal, knee range of motion orthosis. The brace includes range of motion hinges to allow for
00810113683539 - ManaEZ Shoulder Ice CureTech2026-01-12 The ManaEZ Shoulder ice a convenient shoulder orthosis for pain, swelling, and to compress the shoulder joint. Pump up with air
00810113682730 - ManaSlide2025-12-03 ManaSlide is a patient transfer blanket designed to assist in patient positioning in a bed or for moving a patient from a bed to
00810113682969 - ManaEZ Single Panel Knee Immobilizer 18"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113682976 - ManaEZ Single Panel Knee Immobilizer 20"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c
00810113682983 - ManaEZ Single Panel Knee Immobilizer 24"2025-12-03 The soft, breathable design accommodates most leg circumferences, both styles can be adjusted to provide a customized fit. The c

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