Relief+

GUDID 00850056031226

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 ID00850056031226
NIH Device Record Key97c8339a-2cf7-4b45-be7e-d4412161aed0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRelief+
Version Model NumberInsole with Pcell cover, left (2)
Company DUNS161003025
Company NameSolo Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com
Phone(800) 765-6522
EmailCS@sololabs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850056031226 [Primary]

FDA Product Code

KYSInsoles, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-07
Device Publish Date2023-08-30

On-Brand Devices [Relief+]

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

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