FDA.reportPublic FDA data

"TM ""Rehabilitimed"" RP-6K-M UNIp-1 Comfort"

Primary DI
04823097719510
Brand
"TM ""Rehabilitimed"" RP-6K-M UNIp-1 Comfort"
Company
REABILITIMED TOV
Model
RP-6K-M UNIp-1 Comfort
Catalog number
RP-6K-M UNIp-1 Comfort
Device description
It is an orthosis for the shoulder and elbow joint, beige in color. Made of multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth) and designed so that the two sleeves supporting the arm are easily adjusted in height using a textile fastener. Additionally equipped with a belt around the chest to press the arm to the body for its reliable fixation.
Published
2025-05-04
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
IOYSupport, Arm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOYSupport, ArmPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04823097719510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04823097719510048230977195104823097719510

GMDN Terms#

Term, Definition table
TermDefinition
Elbow orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

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
06974500613555Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
06974500613593Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613552Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613590Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
00810113683041Kangaroo 3960Manamed, Inc.IOY2025-10-17
00636257207710MEDIMEDI MANUFACTURING, INC.IOY2025-09-26
00636257204924MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204931MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204948MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
00636257204955MEDIMEDI MANUFACTURING, INC.IOY2025-06-24
04823097723395"TM ""Rehabilitimed"" RP-6 XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723401"TM ""Rehabilitimed"" RP-6 S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723418"TM ""Rehabilitimed"" RP-6 XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723425"TM ""Rehabilitimed"" RP-6 S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723432"TM ""Rehabilitimed"" RP-6 M Comfort"REABILITIMED TOVIOY2025-05-17
04823097723449"TM ""Rehabilitimed"" RP-6 L Comfort"REABILITIMED TOVIOY2025-05-17
04823097723456"TM ""Rehabilitimed"" RP-6 XL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723494"TM ""Rehabilitimed"" RP-6P XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723500"TM ""Rehabilitimed"" RP-6P S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723517"TM ""Rehabilitimed"" RP-6P XS Comfort"REABILITIMED TOVIOY2025-05-17
04823097723524"TM ""Rehabilitimed"" RP-6P S Comfort"REABILITIMED TOVIOY2025-05-17
04823097723531"TM ""Rehabilitimed"" RP-6P M Comfort"REABILITIMED TOVIOY2025-05-17
04823097723548"TM ""Rehabilitimed"" RP-6P L Comfort"REABILITIMED TOVIOY2025-05-17
04823097723555"TM ""Rehabilitimed"" RP-6P XL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723562"TM ""Rehabilitimed"" RP-6K-M UNI Comfort"REABILITIMED TOVIOY2025-05-17
04823097723579"TM ""Rehabilitimed"" RP-6K-M XXL Comfort"REABILITIMED TOVIOY2025-05-17
04823097723586"TM ""Rehabilitimed"" RP-6K-M1 UNIp-2 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723593"TM ""Rehabilitimed"" RP-6K-M1 UNIp-1 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723609"TM ""Rehabilitimed"" RP-6K-M1 UNIp-2 Comfort"REABILITIMED TOVIOY2025-05-17
04823097723616"TM ""Rehabilitimed"" RP-6K-M1 UNIp-1 Comfort"REABILITIMED TOVIOY2025-05-17