Relief

GUDID 00850056031134

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.

Solo Laboratories, Inc.

Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made Orthotic insole, custom-made

• Primary Device ID: 00850056031134
• NIH Device Record Key: 389835a7-2fd4-4c7b-8ac0-e8056d79f6ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Relief
• Version Model Number: Insole with Plastizote cover, left (2)
• Company DUNS: 161003025
• Company Name: Solo Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com
• Phone: (800) 765-6522
• Email: CS@sololabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850056031134 [Primary]

FDA Product Code

• KYS: Insoles, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-07
• Device Publish Date: 2023-08-30

On-Brand Devices [Relief]

• 00850056031172: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031165: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031158: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031141: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031134: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031127: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031110: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031103: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031097: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031080: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031073: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031066: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031059: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031042: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031035: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031028: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031011: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031004: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a