FDA.reportPublic FDA data

COMFYGO

Primary DI
00810203610773
Brand
COMFYGO
Company
ComfyGO, Inc
Model
6011
Catalog number
6011
Device description
Electric Wheelchair
Published
2025-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K070501000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070501000RUIKE 3421 POWERED WHEELCHAIRShanghai Ruike Sports Goods Co., Ltd.2007-03-22ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810203610773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810203610773008102036107738102036107730810203610773

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18447555055info@comfygomobility.com

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
00810203611008ComfyGOZ-4Z-42026-03-10
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
00810203610728ComfyGOG-5G-52025-09-11
00810203610018ComfyGOPhoenixPhoenix2025-07-31

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