FDA.report

MERITS

Primary DI
04714379290653
Brand
MERITS
Company
MERITS HEALTH PRODUCTS CO., LTD.
Model
N473WMDZMU
Published
2019-06-14
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
false

Related Records

Product Codes

CodeName
IORWheelchair, Mechanical

Product Code Classifications

CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04714379290653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04714379290653047143792906534714379290653

GMDN Terms

TermDefinition
Wheelchair, 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. The occupant moves the device by rotating both rear wheels. The device may be disassembled or folded for transport.

Sterilization Methods

Method

Regulatory Flags

DUNS number
657231924
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
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 DIBrandModelCatalogPublished
04714379299328MERITSD14142025-08-08
04714379299335MERITSG14142025-08-08
04714379299342MERITSAP16162025-08-08
04714379299359MERITSL14162025-08-08
04714379298963MERITSP301A-ARMUB2025-06-13
04714379298970MERITSP301A-SBMUB2025-06-13
04714379298987MERITSP301A-SDMUB2025-06-13
04714379298994MERITSP710A-ARMU2025-06-13
04714379299007MERITSP710A-ARMUB2025-06-13
04714379299014MERITSP710A-SBMU2025-06-13
04714379299021MERITSP710A-SBMUB2025-06-13
04714379299366MERITSP301A-ARMU2025-06-13
04714379299373MERITSP301A-SBMU2025-06-13
04714379298925MERITSP3278-BBMUB2025-03-17
04714379292602MERITSP322B1ARMUB2019-07-30
04714379292619MERITSP322B2ARMUB2019-07-30
04714379292626MERITSP322A5ARMUB2019-07-30
04714379292633MERITSP322A6ARMUB2019-07-30
04714379298826MERITSE605P1YLMUB22025-01-10
04714379298833MERITSE605P1YLMUB12025-01-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840363375540KiKI MOBILITY, LLCIOR2026-03-11
00810178884506ViveVIVE HEALTH LLCIOR2026-03-06
00810178885213ViveVIVE HEALTH LLCIOR2026-03-06
00810178885220ViveVIVE HEALTH LLCIOR2026-03-06
00810178885237ViveVIVE HEALTH LLCIOR2026-03-06
00840117408661ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408678ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408685ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408692ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408708ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408715ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
00840117408722ConvaidCONVAID PRODUCTS, INC.IOR2026-03-05
04719873857104KarmaKARMA MOBILITY COMPANY LIMITEDIOR2026-02-25
04719873857395KarmaKARMA MOBILITY COMPANY LIMITEDIOR2026-02-25
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00841447116318Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116325Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116332Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116349Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116356Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116363Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116370Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116387Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00841447116394Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
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00841447116417Easy Glide Wheelchair for InvacareINVACARE CORPORATIONIOR2026-02-13
00840117408180ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05
00840117408197ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05
00840117408203ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05
00840117408210ConvaidCONVAID PRODUCTS, INC.IOR2026-02-05