"DynaRide Reclining Wheelchair 18""x16"" Detach Desk Arm ELR"

Primary DI
00616784023915
Brand
"DynaRide Reclining Wheelchair 18""x16"" Detach Desk Arm ELR"
Company
Dynarex Corporation
Model
10239
Published
2019-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K082784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082784000JUMAO MANUAL WHEELCHAIRDanyang Jumao Healthcare Equipment Co., Ltd.2008-10-07IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784023915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784023915006167840239156167840239150616784023915

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

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