FDA.reportPublic FDA data

Merits

Primary DI
00835246003412
Brand
Merits
Company
Merits Health Products, Inc.
Model
S941L-SDMUB
Catalog number
S941L-SDMUB
Device description
Silverado Extreme S941L, Black, With Batteries
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
INIVehicle, Motorized 3-Wheeled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INIVehicle, Motorized 3-WheeledPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142162000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142162000MERITS TRANSFORMER POWER SCOOTER, S941Merits Health Products Co., Ltd.2015-05-01INI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00835246003412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00835246003412008352460034128352460034120835246003412

GMDN Terms#

Term, Definition table
TermDefinition
Assistive scooter, electric-motor-drivenA battery-powered, electric-motor-driven mobility device designed to be operated by a person with a disability and consisting of a seat over two rear wheels, a platform for the feet, and handlebars in front to turn one or two steerable front wheels connected via a steering-column. Commonly referred to as a mobility scooter, it is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
879307148
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973175531348MOGOAnhui JBH Medical Apparatus Co., Ltd.INI2026-05-09
06978949462149Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-04-29
06978746860155Mobility scooter for disabled and elderlyZhejiang Wei Ling New Energy Technology Co., Ltd.INI2026-04-09
06978746860162Mobility scooter for disabled and elderlyZhejiang Wei Ling New Energy Technology Co., Ltd.INI2026-04-09
06978949462507Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
06978949463061Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
06978949463078Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
06978949463085Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co., LtdINI2026-03-20
00606509300919Go Go Super Portable 2Pride Mobility Products CorpINI2026-03-19
00606509300926Go Go Super Portable HDPride Mobility Products CorpINI2026-03-19
06974857293004Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857293011Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857293301Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857293318Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06974857295800Smarfody Electric ScooterDongguan Smarfody Mobility Technology Co., Ltd.INI2026-03-19
06978074600003MIJONanjing Mijo Technology Co., LtdINI2026-03-17
00810203611008ComfyGOComfyGO, IncINI2026-03-10
04719873857661KarmaKARMA MEDICAL PRODUCTS CO., LTD.INI2026-02-25
00606509300865Baja Wrangler 3Pride Mobility Products CorpINI2026-02-17
00606509300872Ultra X GEN 3Pride Mobility Products CorpINI2026-02-17
00606509300889Elite Traveller GEN 3Pride Mobility Products CorpINI2026-02-17
00606509300896Elite Traveller GEN 3 PlatinumPride Mobility Products CorpINI2026-02-17
06972665816002Nanjing Kangni Smart Technology Co., Ltd.Nanjing Kangni Smart Technology Co., Ltd.INI2026-02-11
06970990830694SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06970990830700SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06970990830717SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06970990830724SolaxGuangdong Prestige Technology Co., Ltd.INI2026-01-08
06975185620173BaichenNINGBO BAICHEN MEDICAL DEVICES CO., LTDINI2026-01-07
04713072962379FREERIDERFREERIDER CORP.INI2026-01-02
04713072962386FREERIDERFREERIDER CORP.INI2026-01-02