FDA.reportPublic FDA data

TM "Rehabilitimed" RP-6K-M1 UNIp-2 Comfort

Primary DI
04823097723586
Brand
TM "Rehabilitimed" RP-6K-M1 UNIp-2 Comfort
Company
REABILITIMED TOV
Model
RP-6K-M1 UNIp-2 Comfort
Catalog number
RP-6K-M1 UNIp-2 Comfort
Device description
The turquoise blue shoulder brace provides a medium degree of fixation of the elbow joint and shoulder girdle. The arm sleeve is easily unfastened with a textile fastener and provides free access. Equipped with a belt girdling the chest with the arm pressed to the body to fix and prevent the arm from being pulled away.
Published
2025-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
04823097723586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04823097723586048230977235864823097723586

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

Regulatory Flags#

DUNS number
364875768
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16974500613552Elbow SupportGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
16974500613590Shoulder BraceGCMEDICA ENTERPRISE LTD.(WUXI)IOY2025-12-12
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
04823097723395TM "Rehabilitimed" RP-6 XS ComfortREABILITIMED TOVIOY2025-05-17
04823097723401TM "Rehabilitimed" RP-6 S ComfortREABILITIMED TOVIOY2025-05-17
04823097723418TM "Rehabilitimed" RP-6 XS ComfortREABILITIMED TOVIOY2025-05-17
04823097723425TM "Rehabilitimed" RP-6 S ComfortREABILITIMED TOVIOY2025-05-17
04823097723432TM "Rehabilitimed" RP-6 M ComfortREABILITIMED TOVIOY2025-05-17
04823097723449TM "Rehabilitimed" RP-6 L ComfortREABILITIMED TOVIOY2025-05-17
04823097723456TM "Rehabilitimed" RP-6 XL ComfortREABILITIMED TOVIOY2025-05-17
04823097723494TM "Rehabilitimed" RP-6P XS ComfortREABILITIMED TOVIOY2025-05-17
04823097723500TM "Rehabilitimed" RP-6P S ComfortREABILITIMED TOVIOY2025-05-17
04823097723517TM "Rehabilitimed" RP-6P XS ComfortREABILITIMED TOVIOY2025-05-17
04823097723524TM "Rehabilitimed" RP-6P S ComfortREABILITIMED TOVIOY2025-05-17
04823097723531TM "Rehabilitimed" RP-6P M ComfortREABILITIMED TOVIOY2025-05-17
04823097723548TM "Rehabilitimed" RP-6P L ComfortREABILITIMED TOVIOY2025-05-17
04823097723555TM "Rehabilitimed" RP-6P XL ComfortREABILITIMED TOVIOY2025-05-17
04823097723562TM "Rehabilitimed" RP-6K-M UNI ComfortREABILITIMED TOVIOY2025-05-17
04823097723579TM "Rehabilitimed" RP-6K-M XXL ComfortREABILITIMED TOVIOY2025-05-17
04823097723593TM "Rehabilitimed" RP-6K-M1 UNIp-1 ComfortREABILITIMED TOVIOY2025-05-17
04823097723609TM "Rehabilitimed" RP-6K-M1 UNIp-2 ComfortREABILITIMED TOVIOY2025-05-17
04823097723616TM "Rehabilitimed" RP-6K-M1 UNIp-1 ComfortREABILITIMED TOVIOY2025-05-17
04823097723623TM "Rehabilitimed" RP-6K-M1 UNI ComfortREABILITIMED TOVIOY2025-05-17
04823097723630TM "Rehabilitimed" RP-6K-M1 XXL ComfortREABILITIMED TOVIOY2025-05-17
04823097719176TM "Rehabilitimed" RP-6 XS ComfortREABILITIMED TOVIOY2025-05-04
04823097719183TM "Rehabilitimed" RP-6 S ComfortREABILITIMED TOVIOY2025-05-04