FDA.reportPublic FDA data

Merits

Primary DI
00835246004549
Brand
Merits
Company
Merits Health Products, Inc.
Model
P325 30200649
Catalog number
P325 30200649
Device description
Velocity VR2 Base, No Power, R-NET Upgradable
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
00835246004549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00835246004549008352460045498352460045490835246004549

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
00835246004556MeritsP325 30200715P325 302007152024-10-02
00835246004563MeritsP325 30200715P325 302007152024-10-02
00835246004570MeritsP325 30200815P325 302008152024-10-02
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
06973175531430MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-30
00860015909206VeloxVelox Manufacturing IncITI2026-05-28
06973134773017sliverfoxSilverfox Corporation LimitedITI2026-05-27
04046727184476e-motion®Alber GmbHITI2026-05-26
04046727184483e-motion®Alber GmbHITI2026-05-26
04046727184490e-motion®Alber GmbHITI2026-05-26
04046727248994e-fix®Alber GmbHITI2026-05-26
04046727250928e-fix®Alber GmbHITI2026-05-26
04046727250935e-fix®Alber GmbHITI2026-05-26
04046727250942e-fix®Alber GmbHITI2026-05-26
04046727250959e-fix®Alber GmbHITI2026-05-26
04046727250966e-fix®Alber GmbHITI2026-05-26
04046727250980e-fix®Alber GmbHITI2026-05-26
04046727250997e-fix®Alber GmbHITI2026-05-26
04046727251000e-fix®Alber GmbHITI2026-05-26
04046727251017e-fix®Alber GmbHITI2026-05-26
04046727251048e-fix®Alber GmbHITI2026-05-26
04046727251055e-fix®Alber GmbHITI2026-05-26
06973717276683Dahao MedicalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-26
06976245010361Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-26
06976245010378Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-26
00199874244891AMP plusMethod Mobility, Inc.ITI2026-05-25
00199874251073AMPMethod Mobility, Inc.ITI2026-05-25
00199874773407AMP jsMethod Mobility, Inc.ITI2026-05-25
06973717276690VerpalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-25
06976245010187Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-25
06975028630116NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Ningbo Youhuan Automation Technology Co., LtdITI2026-05-21
06975028630581NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Ningbo Youhuan Automation Technology Co., LtdITI2026-05-21
06973175531300MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531317MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09