FDA.reportPublic FDA data

TiLite

Primary DI
00853316008075
Brand
TiLite
Company
Tilite
Model
2GX
Published
2020-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072311000TILITE AERO XTisport, LLC2007-09-21IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853316008075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853316008075008533160080758533160080750853316008075

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
059012893
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853316008129TiLiteTiLite X2024-07-16
00853316008136TiLiteTiLite Z2024-07-16
00853316008112TiLiteCR12023-09-22
00853316008006TiLiteAero Z2020-09-23
00853316008013TiLiteAero T2020-09-23
00853316008020TiLiteTR2020-09-23
00853316008037TiLiteTRA2020-09-23
00853316008044TiLiteZR2020-09-23
00853316008051TiLiteZRA2020-09-23
00853316008068TiLiteAero X2020-09-23
00853316008082TiLitePilot2020-09-23
00853316008099TiLiteTwist2020-09-23
00853316008105TiLiteTX2020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05907467831916REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831923REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831930REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831947REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831954REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831961REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831978REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831985REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467831992REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832005REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832012REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832029REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832036REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832043REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832050REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832067REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832074REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832081REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832098REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832104REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832111REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832128REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467832135REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467836249REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467836256REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467836263REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467836270REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467853758REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467853765REHASENSEREHASENSE SP Z O OIOR2026-10-30
05907467853772REHASENSEREHASENSE SP Z O OIOR2026-10-30