FDA.reportPublic FDA data

Celebrity XL 3 Wheel

Primary DI
00606509300063
Brand
Celebrity XL 3 Wheel
Company
PRIDE MOBILITY PRODUCTS CORPORATION
Model
S4350/SC4350
Catalog number
N/A
Device description
A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
INIVehicle, Motorized 3-Wheeled

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606509300063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606509300063006065093000636065093000630606509300063

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. The device 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
041477449
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606509200226R-TRAKR-TRAKN/A2023-02-06
00606509100328GoChair LiGoChair LiN/A2022-08-29
00606509100335GoChairMED LiGoChairMED LiN/A2022-08-29
00606509401524PLR4955PLR4955N/A2022-08-01
00606509500234MM3710MM3710N/A2022-07-22
00606509500241MM3712MM3712N/A2022-07-22
00606509100311Jazzy CarbonJazzy CarbonN/A2022-07-07
00606509100298EVO614EVO614N/A2022-01-04
00606509100304EVO614HDEVO614HDN/A2022-01-04
00606509300612CX3CX3N/A2022-01-04
00606509300605CX4CX4N/A2021-12-29
00606509700122Pro Seating Coolcore Cushion (PRO.111)Pro Seating Coolcore Cushion (PRO.111)N/A2021-09-28
00606509700139Pro Seating Coolcore Cushion (PRO.135)Pro Seating Coolcore Cushion (PRO.135)N/A2021-09-28
00606509700146Pro Seating Coolcore Cushion (PRO.211)Pro Seating Coolcore Cushion (PRO.211)N/A2021-09-28
00606509700153Pro Seating Coolcore Cushion (PRO.315)Pro Seating Coolcore Cushion (PRO.315)N/A2021-09-28
00606509700160Pro Seating Coolcore Cushion (PRO.345)Pro Seating Coolcore Cushion (PRO.345)N/A2021-09-28
00606509700177Pro Seating Coolcore Cushion (PRO.511)Pro Seating Coolcore Cushion (PRO.511)N/A2021-09-28
00606509200219Q6 Edge 2.0 HDQ6 Edge 2.0 HDN/A2021-09-16
00606509500227MM3605MM3605N/A2021-09-02
00606509300599Wrangler/Ranger/OutbackMV600N/A2021-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06970990830656MOBIFREEGuangdong Prestige Technology Co., Ltd.INI2025-12-09
06970990830663SolaxGuangdong Prestige Technology Co., Ltd.INI2025-12-09
B247GC240Scooter, ElectricGOLDEN BROTHERS, INC.INI2025-12-08
B247GC340Scooter, ElectricGOLDEN BROTHERS, INC.INI2025-12-08