ManaEZ Night Splint, Plantar Fasciitis, Large

Basic Information

• Brand Name: ManaEZ Night Splint, Plantar Fasciitis, Large
• Primary DI: 00810113683140
• Version / Model: EZSPNT01-L
• Catalog Number: EZSPNT01-L
• Company Name: Manamed, Inc.
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-26
• Public Version: 1
• Public Version Date: 2025-10-06
• Public Version Status: New
• Public Device Record Key: 0ba3e4d2-ccd7-4a30-9085-91135f70bed5

Device Description

Ideal for patients that need to stretch the Achilles Tendon or Plantar Fascia. Common indications are Plantar Fasciitis, Tight Achilles, Achilles Tendonitis, and conditions where dorsiflexing the foot is part of the rehabilitation protocol. Easy-to-apply universal left/right design available in 3 sizes.

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
66559	Ankle/foot orthosis flexion adjustment device	A prefabricated device intended to be used with an ankle/foot orthosis to assist or limit dorsiflexion or plantar flexion of the ankle/foot. It is typically designed to be strapped around the posterior region of the orthosis and is available in a variety of forms designed to restrict flexion (e.g., static bar, rigid plate) or facilitate flexion (e.g., flexible curved plate). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113683140	GS1

Customer Contacts

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