FDA.reportPublic FDA data

"DynaRide S 4 X-Lite Wheelchair 20""x16""-18 Flip Desk Arm ELR"

Primary DI
00616784027517
Brand
"DynaRide S 4 X-Lite Wheelchair 20""x16""-18 Flip Desk Arm ELR"
Company
Dynarex Corporation
Model
10275
Published
2019-04-01
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
K070176000
K082784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070176000MAXHEALTH MECHANICAL WHEELCHAIR, K1Maxhealth Corp.2007-03-01IOR
K082784000JUMAO MANUAL WHEELCHAIRDanyang Jumao Healthcare Equipment Co., Ltd.2008-10-07IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784027517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784027517006167840275176167840275170616784027517

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784432120Cotton Tipped Plastic Applicators43212021-09-01
00616784432526Wooden Spoon, 3" (7.6 cm)43252026-04-27
00840117313347Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR362602022-05-17
00840117313385Resp-O2 Intubating Stylette, 6 Fr362652022-05-17
00840117313408Resp-O2 Intubating Stylette, 10 Fr362662022-05-17
00840117313422Resp-O2 Intubating Stylette, 12 Fr362672022-05-17
00840117315235Resp-O2 Intubating Stylette, 14 Fr362682022-05-17
00840117317451Resp-O2 Endotracheal Tube Cuffed, 4.0 mm362342024-10-24
00840117317468Resp-O2 Endotracheal Tube Cuffed, 4.5 mm362352024-10-24
00840117317482Resp-O2 Endotracheal Tube Cuffed, 5.5 mm362372024-10-24
00840117317499Resp-O2 Endotracheal Tube Cuffed, 6.0 mm362382024-10-24
00840117317505Resp-O2 Endotracheal Tube Cuffed, 6.5 mm362392024-10-24
00840117317512Resp-O2 Endotracheal Tube Cuffed, 7.0 mm362402024-10-24
00840117317529Resp-O2 Endotracheal Tube Cuffed, 7.5 mm362412024-10-24
00840117317536Resp-O2 Endotracheal Tube Cuffed, 8.0 mm362422024-10-24
00840117317543Resp-O2 Endotracheal Tube Cuffed, 8.5 mm362432024-10-24
00840117317550Resp-O2 Endotracheal Tube, Cuffed, 9.0 mm362442024-10-24
00840117318366Resp-O2 Durable Peak Flow Mouthpiece, With One-Way Valve, Adult361162021-04-22
00840117318373Resp-O2 Cardboard Peak Flow Mouthpiece, Disposable, Pediatric361172021-04-22
00840117318380Resp-O2 Cardboard Peak Flow Mouthpieces, Disposable, Adult361182021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876192295TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IOR2026-07-09
04719876191953TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IOR2026-07-08
04719876192318TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IOR2026-07-08
00822383037127Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037134Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037141Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037158Cruiser 3 16"Drive Devilbiss HealthcareIOR2026-06-22
00822383037165Cruiser 3 18"Drive Devilbiss HealthcareIOR2026-06-22
00822383037172Cruiser 3 20"Drive Devilbiss HealthcareIOR2026-06-22
06970006394691DAYANG MEDICALGuangdong Dayang Medical Technology Co.,LtdIOR2026-06-10
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
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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