FDA.reportPublic FDA data

"TM ""Rehabilitimed"" BR-1 XXL Comfort"

Primary DI
04823097723715
Brand
"TM ""Rehabilitimed"" BR-1 XXL Comfort"
Company
REABILITIMED TOV
Model
BR-1 XXL Comfort
Catalog number
BR-1 XXL Comfort
Device description
It is a graphite colored chest bandage. The part of the bandage that fits to the back is made of elastic fabric, and the front-side parts are made of rich ball material (a special velor tri-laminated fabric (glued in a special way with polyurethane foam) with a rich terry cloth, complete with 2 plastic ribs.
Published
2025-06-19
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
IPXOrthosis, Rib Fracture, Soft

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPXOrthosis, Rib Fracture, SoftPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04823097723715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04823097723715048230977237154823097723715

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Device Sizes#

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

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
04823097721872"TM ""Rehabilitimed"" L-4M-3 S Comfort"L-4M-3 S ComfortL-4M-3 S Comfort2025-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446660576PROCAREDJO, LLCIPX2025-07-23
04823097721650"TM ""Rehabilitimed"" BR-2 S Comfort"REABILITIMED TOVIPX2025-06-19
04823097721667"TM ""Rehabilitimed"" BR-2 M Comfort"REABILITIMED TOVIPX2025-06-19
04823097721674"TM ""Rehabilitimed"" BR-2 L Comfort"REABILITIMED TOVIPX2025-06-19
04823097721681"TM ""Rehabilitimed"" BR-2 XL Comfort"REABILITIMED TOVIPX2025-06-19
04823097721698"TM ""Rehabilitimed"" BR-2 XXL Comfort"REABILITIMED TOVIPX2025-06-19
04823097723678"TM ""Rehabilitimed"" BR-1 S Comfort"REABILITIMED TOVIPX2025-06-19
04823097723685"TM ""Rehabilitimed"" BR-1 M Comfort"REABILITIMED TOVIPX2025-06-19
04823097723692"TM ""Rehabilitimed"" BR-1 L Comfort"REABILITIMED TOVIPX2025-06-19
04823097723708"TM ""Rehabilitimed"" BR-1 XL Comfort"REABILITIMED TOVIPX2025-06-19
04823097706886"TM ""Rehabilitimed"" BR-2 S"REABILITIMED TOVIPX2025-05-04
04823097706893"TM ""Rehabilitimed"" BR-2 M"REABILITIMED TOVIPX2025-05-04
04823097706909"TM ""Rehabilitimed"" BR-2 L"REABILITIMED TOVIPX2025-05-04
04823097706916"TM ""Rehabilitimed"" BR-2 XL"REABILITIMED TOVIPX2025-05-04
04823097706923"TM ""Rehabilitimed"" BR-2 XXL"REABILITIMED TOVIPX2025-05-04
04823097706930"TM ""Rehabilitimed"" BR-2 XXXL"REABILITIMED TOVIPX2025-05-04
04823097706947"TM ""Rehabilitimed"" BR-2 S"REABILITIMED TOVIPX2025-05-04
04823097706954"TM ""Rehabilitimed"" BR-2 M"REABILITIMED TOVIPX2025-05-04
04823097706961"TM ""Rehabilitimed"" BR-2 L"REABILITIMED TOVIPX2025-05-04
04823097706978"TM ""Rehabilitimed"" BR-2 XL"REABILITIMED TOVIPX2025-05-04
04823097706985"TM ""Rehabilitimed"" BR-2 XXL"REABILITIMED TOVIPX2025-05-04
04823097706992"TM ""Rehabilitimed"" BR-2 XXXL"REABILITIMED TOVIPX2025-05-04
00609271950108MECRON Belt B: 22 cm, U: 66-86 cmDarco (Europe) GmbHIPX2023-02-14
00609271950115MECRON Belt B: 22 cm, U: 84-110 cmDarco (Europe) GmbHIPX2023-02-14
00609271950122MECRON Belt B: 22 cm, U: 105-127 cmDarco (Europe) GmbHIPX2023-02-14
00609271950139MECRON Belt B: 22 cm, U: 130-157 cmDarco (Europe) GmbHIPX2023-02-14
00609271950146MECRON Belt B: 29 cm, U: 66-86 cmDarco (Europe) GmbHIPX2023-02-14
00609271950153MECRON Belt B: 29 cm, U: 84-110 cmDarco (Europe) GmbHIPX2023-02-14
00609271950160MECRON Belt B: 29 cm, U: 105-127 cmDarco (Europe) GmbHIPX2023-02-14
00609271950177MECRON Belt B: 29 cm, U: 130-157 cmDarco (Europe) GmbHIPX2023-02-14