FDA.reportPublic FDA data

TM "Rehabilitimed" ORTEZ-2V-1 M-75 Comfort

Primary DI
04823097718216
Brand
TM "Rehabilitimed" ORTEZ-2V-1 M-75 Comfort
Company
REABILITIMED TOV
Model
ORTEZ-2V-1 M-75 Comfort
Catalog number
ORTEZ-2V-1 M-75 Comfort
Device description
It is an orthosis for the cervical spine in the form of an anatomically shaped base made of foamed polyethylene 75 mm high, which has the necessary density and elasticity, and a cover made of multilayer material (special velor triple-layered fabric (glued in a special way with polyurethane foam) with cotton terry cloth) of graphite color. On both sides of the orthosis, a textile fastener is sewn, which allows you to more accurately fix the product around the neck.
Published
2025-05-04
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
IQKOrthosis, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQKOrthosis, CervicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04823097718216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04823097718216048230977182164823097718216

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine collar, single-useA prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a single-use 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

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
16946430425079Lightning X Products, IncXIAMEN COMPOWER MEDICAL TECH. CO., LTDIQK2025-12-24
16974500613606 Cervical CollarGCMEDICA ENTERPRISE LTD.(WUXI)IQK2025-12-12
00749756399395DeRoyalDEROYAL INDUSTRIES, INC.IQK2025-07-23
00749756399401DeRoyalDEROYAL INDUSTRIES, INC.IQK2025-07-23
10810113578801ViveVIVE HEALTH LLCIQK2025-07-08
04823097718131TM "Rehabilitimed" ORTEZ-2V-1 XL-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718148TM "Rehabilitimed" ORTEZ-2V-1 XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097718155TM "Rehabilitimed" ORTEZ-2V-1 XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097718162TM "Rehabilitimed" ORTEZ-2V-1 L-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718179TM "Rehabilitimed" ORTEZ-2V-1 L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097718186TM "Rehabilitimed" ORTEZ-2V-1 L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097718193TM "Rehabilitimed" ORTEZ-2V-1 M-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718209TM "Rehabilitimed" ORTEZ-2V-1 M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719701TM "Rehabilitimed" ORTEZ-2V-1 M-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719718TM "Rehabilitimed" ORTEZ-2V-1 L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719725TM "Rehabilitimed" ORTEZ-2V-1 XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719732TM "Rehabilitimed" ORTEZ-2V-1 M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719749TM "Rehabilitimed" ORTEZ-2V-1 L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719756TM "Rehabilitimed" ORTEZ-2V-1 XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719763TM "Rehabilitimed" ORTEZ-2V-1 M-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719770TM "Rehabilitimed" ORTEZ-2V-1 L-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719787TM "Rehabilitimed" ORTEZ-2V-1 XL-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719909TM "Rehabilitimed" ORTEZ-2V M-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719916TM "Rehabilitimed" ORTEZ-2V L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719923TM "Rehabilitimed" ORTEZ-2V XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719930TM "Rehabilitimed" ORTEZ-2V M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719947TM "Rehabilitimed" ORTEZ-2V L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719954TM "Rehabilitimed" ORTEZ-2V XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719961TM "Rehabilitimed" ORTEZ-2V M-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719978TM "Rehabilitimed" ORTEZ-2V L-110 ComfortREABILITIMED TOVIQK2025-05-04