FDA.reportPublic FDA data

"TM ""Rehabilitimed"" OT-1D-4 S Comfort"

Primary DI
04823097722503
Brand
"TM ""Rehabilitimed"" OT-1D-4 S Comfort"
Company
REABILITIMED TOV
Model
OT-1D-4 S Comfort
Catalog number
OT-1D-4 S Comfort
Device description
The graphite-colored posture corrector provides a medium degree of fixation due to 4 modeled metal stiffeners. The orthosis helps to straighten the spine and ensure its proper position. Made of durable elastic bandage fabric made of polyamide and elastane.
Published
2025-05-17
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
IPTOrthosis, Thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPTOrthosis, ThoracicPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04823097722503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04823097722503048230977225034823097722503

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic spine orthosisA prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. 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
00810178888092CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178888665CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178888894CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889075CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889174CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889259CoreTechVIVE HEALTH LLCIPT2026-05-05
00810178889266CoreTechVIVE HEALTH LLCIPT2026-05-05
00850071315264TrendOrthofix US LLCIPT2026-04-25
00850071315240TrendOrthofix US LLCIPT2026-04-14
00850071315257TrendOrthofix US LLCIPT2026-04-14
00850071315271TrendOrthofix US LLCIPT2026-04-14
00810113682716Tailback2-56Manamed, Inc.IPT2025-09-19
00810113682723Tailback2-64Manamed, Inc.IPT2025-09-19
00860014460807Boston Body Jacket, Single OpeningBoston Brace International, Inc.IPT2025-08-05
00860014460814Boston Body Jacket, Bivalve OpeningBoston Brace International, Inc.IPT2025-08-05
00860014460821Boston Overlap Brace (BOB)Boston Brace International, Inc.IPT2025-08-05
04823097722114"TM ""Rehabilitimed"" OT-1V Mp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722121"TM ""Rehabilitimed"" OT-1V Lp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722138"TM ""Rehabilitimed"" OT-1V S Comfort"REABILITIMED TOVIPT2025-05-17
04823097722145"TM ""Rehabilitimed"" OT-1V Sh Comfort"REABILITIMED TOVIPT2025-05-17
04823097722152"TM ""Rehabilitimed"" OT-1V M Comfort"REABILITIMED TOVIPT2025-05-17
04823097722169"TM ""Rehabilitimed"" OT-1V L Comfort"REABILITIMED TOVIPT2025-05-17
04823097722176"TM ""Rehabilitimed"" OT-1V XL Comfort"REABILITIMED TOVIPT2025-05-17
04823097722183"TM ""Rehabilitimed"" OT-1V Mp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722190"TM ""Rehabilitimed"" OT-1V Lp Comfort"REABILITIMED TOVIPT2025-05-17
04823097722206"TM ""Rehabilitimed"" OT-1V S Comfort"REABILITIMED TOVIPT2025-05-17
04823097722213"TM ""Rehabilitimed"" OT-1V Sh Comfort"REABILITIMED TOVIPT2025-05-17
04823097722220"TM ""Rehabilitimed"" OT-1V M Comfort"REABILITIMED TOVIPT2025-05-17
04823097722237"TM ""Rehabilitimed"" OT-1V L Comfort"REABILITIMED TOVIPT2025-05-17
04823097722244"TM ""Rehabilitimed"" OT-1V XL Comfort"REABILITIMED TOVIPT2025-05-17