FDA.reportPublic FDA data

Relief

Primary DI
00850056031059
Brand
Relief
Company
Solo Laboratories, Inc.
Model
Insole with Pcell cover, left (3)
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
00850056031059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056031059008500560310598500560310590850056031059

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
00850056031028ReliefInsole with Pcell cover, 3 pair2023-08-30
00850056031035ReliefInsole with Pcell cover, left2023-08-30
00850056031042ReliefInsole with Pcell cover, left (2)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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04744946011831ESTCARBON Erismet OUKYS2024-10-29
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04744946011923ESTCARBON Erismet OUKYS2024-10-29
04744946011770ESTCARBON Erismet OUKYS2024-10-28
04744946011749ESTCARBON Erismet OUKYS2024-09-20
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