FDA.reportPublic FDA data

Merits

Primary DI
00835246004570
Brand
Merits
Company
Merits Health Products, Inc.
Model
P325 30200815
Catalog number
P325 30200815
Device description
Ultra P325 Base
Published
2024-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113577000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113577000MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIRMerits Health Products Co., Ltd.2012-05-08ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00835246004570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00835246004570008352460045708352460045700835246004570

GMDN Terms#

Term, Definition table
TermDefinition
Electric-motor-driven wheelchair, occupant-controlledAn electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
879307148
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00835246004471MeritsP325 30200553P325 302005532024-10-02
00835246004488MeritsP325 30200554P325 302005542024-10-02
00835246004495MeritsP325 30200589P325 302005892024-10-02
00835246004501MeritsP325 30200592P325 302005922024-10-02
00835246004518MeritsP325 30200593P325 302005932024-10-02
00835246004525MeritsP325 30200594P325 302005942024-10-02
00835246004532MeritsP325 30200595P325 302005952024-10-02
00835246004549MeritsP325 30200649P325 302006492024-10-02
00835246004556MeritsP325 30200715P325 302007152024-10-02
00835246004563MeritsP325 30200715P325 302007152024-10-02
00835246004587MeritsP325 30500746P325 305007462024-10-02
00835246004594MeritsP325I1AARMUBP325I1AARMUB2024-10-01
00835246004600MeritsP325I1WARMUBP325I1WARMUB2024-10-01
00835246004617MeritsP335 30200724P335 302007242024-10-01
00835246004624MeritsP335N 30200797P335N 302007972024-10-01
00835246004631MeritsP323HD 30200571P323HD 302005712024-10-01
00835246004648MeritsP323HD 302005762024-10-01
00835246004655MeritsP331 30200671P331 302006712024-10-01
00835246004662MeritsP331 30200719P331 302007192024-10-01
00835246003412MeritsS941L-SDMUBS941L-SDMUB2024-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436557351272BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351289BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351296BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351302BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351319BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351326BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351333BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351340BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351357BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351364BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351371BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351388BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351432BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351449BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351456BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351463BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351470BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351487BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351494BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351500BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351517BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351524BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351531BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351548BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351593BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351609BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351616BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351623BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351630BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351647BatecBATEC MOBILITY SL.ITI2026-07-29