FDA.reportPublic FDA data

Varilite

Primary DI
00040818914519
Brand
Varilite
Company
Cascade Designs, Inc.
Model
Icon Back Support
Catalog number
4400121410
Device description
Icon Back, Mid, 14
Published
2023-08-17
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

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
00040818914519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00040818914519000408189145190408189145190040818914519

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00840363371429AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371528AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371603AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371627AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371702AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371764AxiomKI MOBILITY, LLCKNO2025-12-05
00840363371795AxiomKI MOBILITY, 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