FDA.reportPublic FDA data

Relief

Primary DI
00850056031028
Brand
Relief
Company
Solo Laboratories, Inc.
Model
Insole with Pcell cover, 3 pair
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.
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYSInsoles, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYSInsoles, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056031028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056031028008500560310288500560310280850056031028

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic insole, custom-madeA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 765-6522CS@sololabs.com

Regulatory Flags#

DUNS number
161003025
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056031004ReliefInsole with Pcell cover, pair2023-08-30
00850056031011ReliefInsole with Pcell cover, 2 pair2023-08-30
00850056031035ReliefInsole with Pcell cover, left2023-08-30
00850056031042ReliefInsole with Pcell cover, left (2)2023-08-30
00850056031059ReliefInsole with Pcell cover, left (3)2023-08-30
00850056031066ReliefInsole with Pcell cover, right2023-08-30
00850056031073ReliefInsole with Pcell cover, right (2)2023-08-30
00850056031080ReliefInsole with Pcell cover, right (3)2023-08-30
00850056031097ReliefInsole with Plastizote cover, pair2023-08-30
00850056031103ReliefInsole with Plastizote cover, 2 pair2023-08-30
00850056031110ReliefInsole with Plastizote cover, 3 pair2023-08-30
00850056031127ReliefInsole with Plastizote cover, left2023-08-30
00850056031134ReliefInsole with Plastizote cover, left (2)2023-08-30
00850056031141ReliefInsole with Plastizote cover, left (3)2023-08-30
00850056031158ReliefInsole with Plastizote cover, right2023-08-30
00850056031165ReliefInsole with Plastizote cover, right (2)2023-08-30
00850056031172ReliefInsole with Plastizote cover, right (3)2023-08-30
00850056031189Relief+Insole with Pcell cover, pair2023-08-30
00850056031196Relief+Insole with Pcell cover, 2 pair2023-08-30
00850056031202Relief+Insole with Pcell cover, 3 pair2023-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04744946011787ESTCARBON Erismet OUKYS2024-10-29
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04744946011770ESTCARBON Erismet OUKYS2024-10-28
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04744946011756ESTCARBON Erismet OUKYS2024-09-20
04744946011763ESTCARBON Erismet OUKYS2024-09-20
04744946010094ESTCARBON Erismet OUKYS2024-09-09
04744946010100ESTCARBON Erismet OUKYS2024-09-09
04744946010209ESTCARBON Erismet OUKYS2024-09-09
04744946010308ESTCARBON Erismet OUKYS2024-09-09
04744946011886ESTCARBON Erismet OUKYS2024-09-09
04744946011893ESTCARBON Erismet OUKYS2024-09-09
04744946011909ESTCARBON Erismet OUKYS2024-09-09
04744946011930ESTCARBON Erismet OUKYS2024-09-09
04744946011947ESTCARBON Erismet OUKYS2024-09-09
04744946011954ESTCARBON Erismet OUKYS2024-09-09
04744946011961ESTCARBON Erismet OUKYS2024-09-09
04744946011978ESTCARBON Erismet OUKYS2024-09-09
04744946012111ESTCARBON Erismet OUKYS2024-09-09
04744946012128ESTCARBON Erismet OUKYS2024-09-09
04744946012135ESTCARBON Erismet OUKYS2024-09-09
04744946012142ESTCARBON Erismet OUKYS2024-09-09
04744946012159ESTCARBON Erismet OUKYS2024-09-09
04744946012166ESTCARBON Erismet OUKYS2024-09-09