FDA.reportPublic FDA data

Merits

Primary DI
00835246004563
Brand
Merits
Company
Merits Health Products, Inc.
Model
P325 30200715
Catalog number
P325 30200715
Device description
Ultra X P325 Base 330Lbs
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
00835246004563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00835246004563008352460045638352460045630835246004563

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
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
00841447198116INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198123INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198130INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198147INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198154INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198161INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198178INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198185INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198192INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198208INVACARE® PRONTO® M61™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198215INVACARE® PRONTO® 31 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198222INVACARE® PRONTO® 31 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198239INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGINVACARE CORPORATIONITI2026-09-20
00841447198246INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGINVACARE CORPORATIONITI2026-09-20
00841447198253INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198260INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198277INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198284INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198291INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198307INVACARE® PRONTO® M41™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198314INVACARE® PRONTO® M51™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198321INVACARE® PRONTO® M41™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198338INVACARE® PRONTO® M51™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198345INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198352INVACARE® PRONTO® M91™ POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198369INVACARE® 3G STORM SERIES® ARROW® POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198376INVACARE® TDX® SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198383INVACARE® 3G STORM SERIES® TORQUE™ SP POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198390INVACARE® TDX® SR POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20
00841447198406INVACARE® 3G STORM SERIES® TORQUE™ 3 POWER WHEELCHAIRINVACARE CORPORATIONITI2026-09-20