ManaGO71 Ankle Brace Large MGO71L

GUDID 00810113683331

The ManaGO 71 provides three different levels of support in one brace. The unique design allows components to be removed as the patient's condition improves. In its extended gauntlet configuration, the ManaGO 71 provides maximum protection for ankle sprains and Syndesmosis injuries. The gauntlet and hinge stirrup with footplate captures the entire ankle mechanism. Removable upper cuff and hinge stirrup with footplate can be removed as recovery improves. Features: Speed lacing ankle foot brace that extends to boot height on the calf Interlocking plastic plates and hinge assembly Figure-eight strapping

Manamed, Inc.

Ankle/foot orthosis
Primary Device ID00810113683331
NIH Device Record Keyd5caa1c4-0772-4a9c-b2bf-f7094e6411d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameManaGO71 Ankle Brace Large
Version Model NumberMGO71L
Catalog NumberMGO71L
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

Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810113683331 [Primary]

FDA Product Code

ITWJoint, Ankle, External Brace

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-06
Device Publish Date2025-09-26

Devices Manufactured by Manamed, Inc.

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