FDA.reportPublic FDA data

APPUI-TETE REGLABLE AMOVIBLE/ ADJUSTABLE HEADREST

Primary DI
03664560000176
Brand
APPUI-TETE REGLABLE AMOVIBLE/ ADJUSTABLE HEADREST
Company
SARL VIPAMAT
Model
0008-00-05
Published
2018-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQCWheelchair, Special Grade

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQCWheelchair, Special GradePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051709000HIPPOCAMPE WHEELCHAIRVipamat Technologie2005-08-15IQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664560000176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664560000176036645600001763664560000176

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair/chair/stander headrestA padded device attached to a wheelchair, a disability-supportive chair, and/or a stander to provide a disabled patient with additional head support and comfort while in a sitting and/or standing position. This device will also include the extensions (e.g., a metal insert, screws) needed to attach this device. It may be available in various shapes and sizes, and it may be adjustable.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+330297862487mfabre@janton-solutions.com

Regulatory Flags#

DUNS number
264013397
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664560000008FAUTEUIL HIPPOCAMPE L BLEU MARBRE/ WHEELCHAIR HIPPOCAMPE L BLUE MARBLED0001-TL-02-BM2017-05-26
03664560000015FAUTEUIL HIPPOCAMPE L ROSE/ WHEELCHAIR HIPPOCAMPE L PINK0001-TL-02-RO2017-05-26
03664560000022FAUTEUIL HIPPOCAMPE M BLEU MARBRE/ WHEELCHAIR HIPPOCAMPE M BLUE MARBLED0001-TM-02-BM2017-05-26
03664560000039FAUTEUIL HIPPOCAMPE M ROSE/ WHEELCHAIR HIPPOCAMPE M PINK0001-TM-02-RO2017-05-26
03664560000046FAUTEUIL HIPPOCAMPE S BLEU MARBRE/ WHEELCHAIR HIPPOCAMPE S BLUE MARBLED0001-TS-02-BM2017-05-26
03664560000053FAUTEUIL HIPPOCAMPE S ROSE/ WHEELCHAIR HIPPOCAMPE S PINK0001-TS-02-RO2017-05-26
03664560000060FAUTEUIL HIPPOCAMPE XL BLEU MARBRE/ WHEELCHAIR HIPPOCAMPE XL BLUE MARBLED0001-XL-02-BM2017-05-26
03664560000077FAUTEUIL HIPPOCAMPE XL ROSE/ WHEELCHAIR HIPPOCAMPE XL PINK0001-XL-02-RO2017-05-26
03664560000084FAUTEUIL HIPPOCAMPE PISCINE/ WHEELCHAIR SWIMMING POOL HIPPOCAMPE0002-TS-022017-05-26
03664560000091DOSSIER FIXE EN HAUTEUR ET INCLINABLE/ FIXED SEAT BACK FRAME0004-00-012017-05-26
03664560000107DOSSIER REGLABLE EN HAUTEUR INCLINABLE/ ADJUSTABLE SEAT BACK FRAME0005-00-012017-05-26
03664560000114FREINS/ BRAKES (PAIR)0006-00-012017-05-26
03664560000121ACCOUDOIRS ESCAMOTABLE REGLABLE ET ORIENTABLE BLEU MARBRE/ ARMRESTS BLUE MARBLED0007-00-02-BM2017-05-26
03664560000138ACCOUDOIRS ESCAMOTABLE REGLABLE ET ORIENTABLE ROSE/ ARMRESTS PINK0007-00-02-RO2017-05-26
03664560000602FAUTEUIL HIPPOCAMPE MARATHON XL NOIR / WHEELCHAIR MARATHON HIPPOCAMPE XL BLACK0040-TX-032026-03-03
03664560000619FAUTEUIL HIPPOCAMPE MARATHON M NOIR / WHEELCHAIR MARATHON HIPPOCAMPE M BLACK0040-TM-032026-03-03
03664560000626FAUTEUIL HIPPOCAMPE MARATHON L NOIR / WHEELCHAIR MARATHON HIPPOCAMPE L BLACK0040-TL-032026-03-03
03664560000510ACCOUDOIRS REGLABLES ET ORIENTABLES NOIR / ARMRESTS BLACK0007-00-022026-02-26
03664560000565PAIRE ROUES TRAIL 24 POUCES POUR FREIN A DISQUE / PAIR OF TRAIL WHEELS 24 INCHES0047-00-012026-02-26
03664560000145APPUI-TETE REGLABLE AMOVIBLE/ ADJUSTABLE HEADREST0008-00-042017-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03664560000602FAUTEUIL HIPPOCAMPE MARATHON XL NOIR / WHEELCHAIR MARATHON HIPPOCAMPE XL BLACKSARL VIPAMATIQC2026-03-03
03664560000619FAUTEUIL HIPPOCAMPE MARATHON M NOIR / WHEELCHAIR MARATHON HIPPOCAMPE M BLACKSARL VIPAMATIQC2026-03-03
03664560000626FAUTEUIL HIPPOCAMPE MARATHON L NOIR / WHEELCHAIR MARATHON HIPPOCAMPE L BLACKSARL VIPAMATIQC2026-03-03
03664560000510ACCOUDOIRS REGLABLES ET ORIENTABLES NOIR / ARMRESTS BLACKSARL VIPAMATIQC2026-02-26
03664560000565PAIRE ROUES TRAIL 24 POUCES POUR FREIN A DISQUE / PAIR OF TRAIL WHEELS 24 INCHESSARL VIPAMATIQC2026-02-26
03664560000008FAUTEUIL HIPPOCAMPE L BLEU MARBRE/ WHEELCHAIR HIPPOCAMPE L BLUE MARBLEDSARL VIPAMATIQC2017-05-26
03664560000015FAUTEUIL HIPPOCAMPE L ROSE/ WHEELCHAIR HIPPOCAMPE L PINKSARL VIPAMATIQC2017-05-26
03664560000022FAUTEUIL HIPPOCAMPE M BLEU MARBRE/ WHEELCHAIR HIPPOCAMPE M BLUE MARBLEDSARL VIPAMATIQC2017-05-26
03664560000039FAUTEUIL HIPPOCAMPE M ROSE/ WHEELCHAIR HIPPOCAMPE M PINKSARL VIPAMATIQC2017-05-26
03664560000046FAUTEUIL HIPPOCAMPE S BLEU MARBRE/ WHEELCHAIR HIPPOCAMPE S BLUE MARBLEDSARL VIPAMATIQC2017-05-26
03664560000053FAUTEUIL HIPPOCAMPE S ROSE/ WHEELCHAIR HIPPOCAMPE S PINKSARL VIPAMATIQC2017-05-26
03664560000060FAUTEUIL HIPPOCAMPE XL BLEU MARBRE/ WHEELCHAIR HIPPOCAMPE XL BLUE MARBLEDSARL VIPAMATIQC2017-05-26
03664560000077FAUTEUIL HIPPOCAMPE XL ROSE/ WHEELCHAIR HIPPOCAMPE XL PINKSARL VIPAMATIQC2017-05-26
03664560000084FAUTEUIL HIPPOCAMPE PISCINE/ WHEELCHAIR SWIMMING POOL HIPPOCAMPESARL VIPAMATIQC2017-05-26
03664560000091DOSSIER FIXE EN HAUTEUR ET INCLINABLE/ FIXED SEAT BACK FRAMESARL VIPAMATIQC2017-05-26
03664560000107DOSSIER REGLABLE EN HAUTEUR INCLINABLE/ ADJUSTABLE SEAT BACK FRAMESARL VIPAMATIQC2017-05-26
03664560000114FREINS/ BRAKES (PAIR)SARL VIPAMATIQC2017-05-26
03664560000121ACCOUDOIRS ESCAMOTABLE REGLABLE ET ORIENTABLE BLEU MARBRE/ ARMRESTS BLUE MARBLEDSARL VIPAMATIQC2017-05-26
03664560000138ACCOUDOIRS ESCAMOTABLE REGLABLE ET ORIENTABLE ROSE/ ARMRESTS PINKSARL VIPAMATIQC2017-05-26
03664560000145APPUI-TETE REGLABLE AMOVIBLE/ ADJUSTABLE HEADRESTSARL VIPAMATIQC2017-05-26
03664560000152ROUES BALLON/ BALLOON WHEELS WITH SUPPORT AXLESARL VIPAMATIQC2017-05-26