FDA.reportPublic FDA data

"TM ""Rehabilitimed"" DS-1 UNI Comfort"

Primary DI
04823097716854
Brand
"TM ""Rehabilitimed"" DS-1 UNI Comfort"
Company
REABILITIMED TOV
Model
DS-1 UNI Comfort
Catalog number
DS-1 UNI Comfort
Device description
It has the appearance of an open structure in the form of a boot, to which a transverse crossbar is attached, which prevents rotation of the foot and the entire leg to the right, left, and additional fixing straps keep the foot from bending movements up and down. Graphite color.
Published
2025-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ITWJoint, Ankle, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04823097716854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04823097716854048230977168544823097716854

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
835 5030395Krut.Lora@gmail.com
+380965139983shenyalipinskiy@gmail.com
+380937042825reabilitimed@ukr.net

Regulatory Flags#

DUNS number
364875768
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04823097718223"TM ""Soloventex"" 621-142 S"621-142 S621-142 S2025-06-26
04823097718230"TM ""Soloventex"" 621-142 M"621-142 M621-142 M2025-06-26
04823097718247"TM ""Soloventex"" 621-142 L"621-142 L621-142 L2025-06-26
04823097718254"TM ""Soloventex"" 621-142 XL"621-142 XL621-142 XL2025-06-26
04823097718261"TM ""Soloventex"" 621-142 XXL"621-142 XXL621-142 XXL2025-06-26
04823097718278"TM ""Soloventex"" 621-132 S"621-132 S621-132 S2025-06-26
04823097718285"TM ""Soloventex"" 621-132 M"621-132 M621-132 M2025-06-26
04823097718292"TM ""Soloventex"" 621-132 L"621-132 L621-132 L2025-06-26
04823097718308"TM ""Soloventex"" 621-132 XL"621-132 XL621-132 XL2025-06-26
04823097718315"TM ""Soloventex"" 621-132 XXL"621-132 XXL621-132 XXL2025-06-26
04823097721650"TM ""Rehabilitimed"" BR-2 S Comfort"BR-2 S ComfortBR-2 S Comfort2025-06-19
04823097721667"TM ""Rehabilitimed"" BR-2 M Comfort"BR-2 M ComfortBR-2 M Comfort2025-06-19
04823097721674"TM ""Rehabilitimed"" BR-2 L Comfort"BR-2 L ComfortBR-2 L Comfort2025-06-19
04823097721681"TM ""Rehabilitimed"" BR-2 XL Comfort"BR-2 XL ComfortBR-2 XL Comfort2025-06-19
04823097721698"TM ""Rehabilitimed"" BR-2 XXL Comfort"BR-2 XXL ComfortBR-2 XXL Comfort2025-06-19
04823097723678"TM ""Rehabilitimed"" BR-1 S Comfort"BR-1 S ComfortBR-1 S Comfort2025-06-19
04823097723685"TM ""Rehabilitimed"" BR-1 M Comfort"BR-1 M ComfortBR-1 M Comfort2025-06-19
04823097723692"TM ""Rehabilitimed"" BR-1 L Comfort"BR-1 L ComfortBR-1 L Comfort2025-06-19
04823097723708"TM ""Rehabilitimed"" BR-1 XL Comfort"BR-1 XL ComfortBR-1 XL Comfort2025-06-19
04823097723715"TM ""Rehabilitimed"" BR-1 XXL Comfort"BR-1 XXL ComfortBR-1 XXL Comfort2025-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889723ViveVIVE HEALTH LLCITW2026-05-27
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00810178889761ViveVIVE HEALTH LLCITW2026-05-27
00810178889778ViveVIVE HEALTH LLCITW2026-05-27
00810178889785ViveVIVE HEALTH LLCITW2026-05-27
00810178889792ViveVIVE HEALTH LLCITW2026-05-27
00810178889808ViveVIVE HEALTH LLCITW2026-05-27
00810178889815ViveVIVE HEALTH LLCITW2026-05-27
00810178889822ViveVIVE HEALTH LLCITW2026-05-27
00810178889839ViveVIVE HEALTH LLCITW2026-05-27
00810178889846ViveVIVE HEALTH LLCITW2026-05-27
00810178889853ViveVIVE HEALTH LLCITW2026-05-27
00810178889860ViveVIVE HEALTH LLCITW2026-05-27
00810178889877ViveVIVE HEALTH LLCITW2026-05-27
00810178889884ViveVIVE HEALTH LLCITW2026-05-27
00810178889891ViveVIVE HEALTH LLCITW2026-05-27
00810178889907ViveVIVE HEALTH LLCITW2026-05-27
00810178889914ViveVIVE HEALTH LLCITW2026-05-27
00749756880169DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756880183DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888127DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888134DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888141DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888158DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00810113579801ViveVIVE HEALTH LLCITW2025-05-20
00810113579818ViveVIVE HEALTH LLCITW2025-05-20
00810113579429CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579436CoreTechVIVE HEALTH LLCITW2024-10-24