FlexSafe Ankle Recovery Orthosis, Extra Large

Basic Information

• Brand Name: FlexSafe Ankle Recovery Orthosis, Extra Large
• Primary DI: 00810113683928
• Version / Model: EZARO-01XL
• Catalog Number: EZARO-01XL
• Company Name: Manamed, Inc.
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-31
• Public Version: 1
• Public Version Date: 2025-11-10
• Public Version Status: New
• Public Device Record Key: cf5c082b-598e-43a0-a12d-627e8205527d

Device Description

The FlexSafe Ankle Recovery Orthosis is a tall pneumatic walker boot built with a unique rocker bottom to simulate natural gait and is open on the medial/lateral sides. Athletic bottom design Large air bladder creates a larger surface for contact pressure to control swelling and ensure snug fit Open sides to allow for less friction on surgical incision sites 4 D-ring hook and loop closures

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITW	Joint, Ankle, External Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10667	Cast boot	A boot-like device designed to be attached around a leg cast to protect and support the cast, and to assist with patient mobility. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and removal. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113683928	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]