FDA.reportPublic FDA data

Flyer

Primary DI
10840117400105
Brand
Flyer
Company
CONVAID PRODUCTS, INC.
Model
FL12
Catalog number
905088
Device description
Flyer models are manual wheelchairs intended to provide mobility to a person with disabilities who is permanently or partially non-ambulatory and limited to a seated position.
Published
2021-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical
LBEStroller, Adaptive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1
LBEStroller, AdaptivePhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171017000Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16TConvaid Products, LLC2017-10-18IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840117400105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084011740010510840117400105

GMDN Terms#

Term, Definition table
TermDefinition
Transport wheelchair, collapsibleA wheeled personal mobility device designed for transporting persons (not bariatric) over a short distance and generally limited to indoor use or use outdoors over smooth paved surfaces. It has small wheels that the occupant cannot use for propulsion and incorporates a simple seat-support system for a person with a disability or a person without the full capacity to walk. It will also include footrests to keep the occupant's feet raised from the ground. It is typically used in hospitals, institutions, airports, and railway stations. Also known as a transportation chair or transit wheelchair, it may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 844 876 6245convaidsales.us@etac.com

Regulatory Flags#

DUNS number
011245388
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117408739ConvaidCoaster 12 Australia8001252026-04-10
00840117408746ConvaidCoaster 14 Australia8001452026-04-10
00840117408753ConvaidCoaster 16 Australia8001652026-04-10
00840117408760ConvaidCoaster 18 Australia8001852026-04-10
00840117408777ConvaidCoaster 12 Scout Transit Australia8001262026-04-10
00840117408784ConvaidCoaster 14 Scout Transit Australia8001462026-04-10
00840117408791ConvaidCoaster 16 Scout Transit Australia8001662026-04-10
00840117408807ConvaidCoaster 18 Scout Transit Australia8001862026-04-10
10840117400365ConvaidSafari 169005262023-01-16
10840117401072ConvaidSafari 189024322023-01-16
00840117408661ConvaidReno 129054982026-03-05
00840117408678ConvaidReno 149054992026-03-05
00840117408685ConvaidReno 169055002026-03-05
00840117408692ConvaidTR Mobility Frame9046612026-03-05
00840117408708ConvaidTR Mobility Frame TransitC9053622026-03-05
00840117408715ConvaidTR Seating System 129055152026-03-05
00840117408722ConvaidTR Seating System 149055162026-03-05
00840117408623ConvaidTR-14 Trekker Base Standard9046612026-02-05
00840117408630ConvaidTR-14 Trekker Base Transit9053622026-02-05
00840117408647ConvaidTR 14 Trekker Seat Module9047682026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975996304019Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304026Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304033Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304040Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304057Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
00810178884865Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885008Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885961Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885978Vive MobilityVIVE HEALTH LLCIOR2026-04-26
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36868282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868282250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31