FDA.reportPublic FDA data

i-Fit

Primary DI
00606509900089
Brand
i-Fit
Company
Pride Mobility Products Corp
Model
i-Fit
Catalog number
N/A
Device description
A padded and contoured device designed to attach to the back of a wheelchair to provide the wheelchair occupant with head and trunk postural support and comfort.
Published
2019-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

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
00606509900089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606509900089006065099000896065099000890606509900089

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair head/trunk supportA padded and contoured device designed to attach to the back of a wheelchair to provide the wheelchair occupant with head and trunk postural support and comfort.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041477449
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606509300919Go Go Super Portable 2SC15M2N/A2026-03-19
00606509300926Go Go Super Portable HDSC15HDN/A2026-03-19
00606509300865Baja Wrangler 3BA403N/A2026-02-17
00606509300872Ultra X GEN 3SC493N/A2026-02-17
00606509300889Elite Traveller GEN 3SC443EN/A2026-02-17
00606509300896Elite Traveller GEN 3 PlatinumSC443EMSN/A2026-02-17
00606509500418MM5401MM5401N/A2026-02-03
00606509500425MM5640MM5640N/A2026-02-03
00606509100403Jazzy EVO 613 AirJazzy EVO 613 AirN/A2025-11-14
00606509401685LC435PWLC435PWN/A2025-11-14
00606509100380Jazzy Carbon 27Jazzy Carbon 27N/A2025-10-10
00606509100397Jazzy Carbon HDJazzy Carbon HDN/A2025-10-10
00606509500401MM6420MM6420N/A2025-09-05
00606509100373Jazzy Carbon 27 XJazzy Carbon 27 XN/A2025-08-08
00606509500395MM8955MM8955N/A2025-08-07
00606509500326MM3600MM3600N/A2025-08-05
00606509500371MM8945MM8945N/A2025-08-05
00606509500388Rascal Carbon CruiserRascal Carbon CruiserN/A2025-05-15
00606509200288Q6 Edge 4Q6 Edge 4N/A2025-05-08
00606509300858Go Go Endurance AL+SC54ALXN/A2025-04-04

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