FDA.reportPublic FDA data

Baichen

Primary DI
06975185620104
Brand
Baichen
Company
NINGBO BAICHEN MEDICAL DEVICES CO., LTD
Model
Sonix BC-EA8000-530
Published
2025-08-06
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
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250475000Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)Ningbo Baichen Medical Devices Co., Ltd.2025-05-27ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975185620104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975185620104069751856201046975185620104

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
707021891
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975185620159BaichenCrutches2026-01-07
06975185620166BaichenWalking Cane2026-01-07
06975185620173BaichenBC-MS3102026-01-07
06975185620050BaichenRubicon BC-EC80022025-08-06
06975185620067BaichenRubicon BC-EA80002025-08-06
06975185620074BaichenRubicon BC-EA55162025-08-06
06975185620081BaichenRubicon BC-EC80032025-08-06
06975185620098BaichenRubicon BC-EALD32025-08-06
06975185620111BaichenSonix BC-EA55152025-08-06
06975185620128BaichenSonix BC-EA8000-90002025-08-06
06975185620135BaichenRubicon2025-08-06
06975185620142BaichenSonix2025-08-06
06975185620012BaichenBC-EA55162025-07-02
06975185620029Baichen BC-EC80022025-07-02
06975185620036BaichenBC-EC80032025-07-02
06975185620043BaichenBC-EALD32025-07-02
06975185620005BaichenBC-EA80002025-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06973175531324MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09