FDA.reportPublic FDA data

Hubang

Primary DI
06944387010181
Brand
Hubang
Company
Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd.
Model
HBLD3-E
Published
2025-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
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
K240913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240913000Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd2024-05-31ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944387010181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944387010181069443870101816944387010181

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
527976711
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944387010150HubangHBLD3-B2025-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974842142072Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142089Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142096Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142133RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842141693Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-07
06974665661095EldHilfeYongkang Youha Electric Appliance Co.,LtdITI2026-06-24
06977027831099CHINFREANZhejiang Nysin Medical Co.,LtdITI2026-06-23
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