Relief+

GUDID 00850056031264

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

• Primary Device ID: 00850056031264
• NIH Device Record Key: aa91cdac-efc1-40e7-8f74-64bbf4920150
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Relief+
• Version Model Number: Insole with Pcell cover, right (3)
• 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	00850056031264 [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+]

• 00850056031356: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031349: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031332: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031325: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031318: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031301: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031295: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031288: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031271: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031264: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031257: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031240: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031233: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031226: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031219: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031202: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031196: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a
• 00850056031189: Ideal for the sensitive diabetic foot, the SOLO Relief® and SOLO Relief+® are A5514 Medicare a