Relief

Basic Information

• Brand Name: Relief
• Primary DI: 00850056031097
• Version / Model: Insole with Plastizote cover, pair
• Company Name: Solo Laboratories, Inc.
• Labeler DUNS: 161003025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-30
• Public Version: 1
• Public Version Date: 2023-09-07
• Public Version Status: New
• Public Device Record Key: 8f5ad41c-a323-4f36-bbbe-a3a7c1135ec4

Device Description

Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare approved inserts. The Relief and Relief+ Custom Orthotic are indicated for Type I Diabetics and Type II Diabetics with pre-ulcerative calluses, poor circulation, diabetics ulcers, previous amputations or partial amputation of either foot.

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: 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: No
• Has Manufacturing Date: No
• 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
KYS	Insoles, Medical	General Hospital	880.6280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62870	Orthotic insole, custom-made	A shoe insert intended to provide supplemental support for the sole, arch, and/or heel of the foot and specifically produced to meet an individual's special requirements, having been prescribed by a relevant healthcare professional. It is made of various materials (e.g., cork, rubber, foam, textile) and may be of modular design by assembly of various pre-made components. This is a reusable device intended for single-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850056031097	GS1

Customer Contacts

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