Home › Manamed, Inc. › ManaEZ ROM Ice Short

ManaEZ ROM Ice Short

Manamed, Inc. · Model EZR001-XSM · UDI-DI 00810113683065

ITQ IME

510(k) clearances

489

Adverse events

Recalls

454

Facilities

Description

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

Recalls

Date	Firm	Reason
2020-06-18	Mueller Sports Medicine, Inc	Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".
2019-11-21	DeRoyal Industries Inc	The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
2016-02-24	Ossur H / F	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,
2015-11-12	Corflex	Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.