Position Health® Classic Post-Op Shoe

Basic Information

• Brand Name: Position Health® Classic Post-Op Shoe
• Primary DI: G0648317270042370
• Version / Model: 831727004237
• Company Name: POSITION HEALTH, LLC
• Labeler DUNS: 116685742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-27
• Public Version: 2
• Public Version Date: 2025-11-26
• Public Version Status: Update
• Public Device Record Key: ba12fd6e-56d8-479a-890f-d817932341d9

Device Description

Position Health® Classic Closed Square Toe Post-Op Offloading Shoe. Color-Black. Size-X-Large.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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
KNP	Orthosis, Corrective Shoe	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31041	Orthotic shoe, non-customized	A prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G0648317270042370	HIBCC

Customer Contacts

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