FDA.reportPublic FDA data

Varilite

Primary DI
00040818914618
Brand
Varilite
Company
Cascade Designs, Inc.
Model
Icon Back Support
Catalog number
4400122010
Device description
Icon Back, Mid, 20
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNOACCESSORIES, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00040818914618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00040818914618000408189146180408189146180040818914618

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair back restA padded support (typically vinyl covered) designed to attach to the back of a wheelchair. It typically replaces the wheelchair's sling upholstery and provides the wheelchair occupant with improved back support, posture, air circulation, and comfort.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)827-4548info@varilite.com

Regulatory Flags#

DUNS number
147973056
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00040818074251VariliteIcon Back Support74252023-08-17
00040818074268VariliteIcon Back Support74262023-08-17
00040818074275VariliteIcon Back Support74272023-08-17
00040818074282VariliteIcon Back Support74282023-08-17
00040818074299VariliteIcon Back Support74292023-08-17
00040818074305VariliteIcon Back Support74302023-08-17
00040818074312VariliteIcon Back Support74312023-08-17
00040818074329VariliteIcon Back Support74322023-08-17
00040818074336VariliteIcon Back Support74332023-08-17
00040818074343VariliteIcon Back Support74342023-08-17
00040818074350VariliteIcon Back Support74352023-08-17
00040818074367VariliteIcon Back Support74362023-08-17
00040818500309VariliteStratus500302023-08-17
00040818500408VariliteStratus500402023-08-17
00040818508305VariliteStratus508302023-08-17
00040818508404VariliteStratus508402023-08-17
00040818522301VariliteStratus522302023-08-17
00040818522400VariliteStratus522402023-08-17
00040818524305VariliteStratus524302023-08-17
00040818524404VariliteStratus524402023-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178884643ViveVIVE HEALTH LLCKNO2026-03-06
00810178884766ViveVIVE HEALTH LLCKNO2026-03-06
00810178884773ViveVIVE HEALTH LLCKNO2026-03-06
00810178884780ViveVIVE HEALTH LLCKNO2026-03-06
00810178884575ViveVIVE HEALTH LLCKNO2025-12-05
00810178884889ViveVIVE HEALTH LLCKNO2025-12-05
00810178884896ViveVIVE HEALTH LLCKNO2025-12-05
00810178884902ViveVIVE HEALTH LLCKNO2025-12-05
00840363373645AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373706AxiomKI MOBILITY, LLCKNO2025-12-04
00840363373874AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374680AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374796AxiomKI MOBILITY, LLCKNO2025-12-04
00840363374871AxiomKI MOBILITY, LLCKNO2025-12-04
00840363375144AxiomKI MOBILITY, LLCKNO2025-12-04
00840363375441AxiomKI MOBILITY, LLCKNO2025-12-04
00840363369631AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369693AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370446AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370545AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370651AxiomKI MOBILITY, LLCKNO2025-12-02
00840363370811AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371047AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371054AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371160AxiomKI MOBILITY, LLCKNO2025-12-02
00840363371337AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369617AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369624AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369648AxiomKI MOBILITY, LLCKNO2025-12-02
00840363369655AxiomKI MOBILITY, LLCKNO2025-12-02