FDA.reportPublic FDA data

ComfyGO

Primary DI
00810203611008
Brand
ComfyGO
Company
ComfyGO, Inc
Model
Z-4
Catalog number
Z-4
Device description
Mobility Scooter
Published
2026-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K242975000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242975000Mobility Scooter (Model X-01, X-02)Wuyi Aichi Industry & Trade Co., Ltd.2025-05-07INI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810203611008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810203611008008102036110088102036110080810203611008

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18447555055info@comfygo.us

Regulatory Flags#

DUNS number
094882026
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810203610940ComfyGOX-9X-92026-03-10
00810203610407ComfyGOIQ-9000IQ-90002026-01-07
00810203610568ComfyGOIQ-8000IQ-80002026-01-07
00810203610797ComfyGOX-1X-12026-01-07
00810203610827ComfyGOX-6X-62026-01-07
00810203610773COMFYGO601160112025-09-12
00810203610728ComfyGOG-5G-52025-09-11
00810203610018ComfyGOPhoenixPhoenix2025-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00606509300933Go Go Super Portable 2Pride Mobility Products CorpINI2026-10-23
06973079880139SweetrichSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880153SweetrichSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880337SweetrichSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880542Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880559Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880566Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880573Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880580Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880597Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880603Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880610Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880627Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880634Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880641Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
06973079880658Metro MobilitySUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-09-23
04713072963666FREERIDERFREERIDER CORP.INI2026-07-31
04713072963680FREERIDERFREERIDER CORP.INI2026-07-31
06973079880450IMOVESUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-07-20
00810226441118Vive MobilityVIVE HEALTH LLCINI2026-07-14
06973079880443TRAVEL BUGGYSUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTDINI2026-06-14
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