FDA.reportPublic FDA data

PORTOLA TECH LLC

Primary DI
06977027830832
Brand
PORTOLA TECH LLC
Company
Zhejiang Nysin Medical Co.,Ltd
Model
NXN20-211
Published
2025-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K241603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241603000Powered Wheelchair (NXN20-208, NXN20-211)Zhejiang Nysin Medical Co., Ltd.2024-11-20ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977027830832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977027830832069770278308326977027830832

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).

Contacts#

Phone, Email table
PhoneEmail
19499660643info@portomobility.com

Regulatory Flags#

DUNS number
632947785
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977027830917A NaicinNXN20-2082026-02-27
06977027830924A NaicinXFGW25-2032026-02-27
06977027830931A NaicinNXN20-2112026-02-27
06977027830900Call of OasisXFGW25-2032026-01-29
06977027830887JustHeroNXN20-2092026-01-12
06977027830894JustHeroXFGW25-2032026-01-12
06977027830849ZiiLIFNXN20-2092025-10-29
06977027830825Call of OasisNXN20-2082025-09-15
06977027830795All Star WheelchairsXFGW30-1072025-08-26
06977027830801All Star WheelchairsNXN20-2092025-08-26
06977027830818All Star WheelchairsNXN20-2082025-08-26
06977027830788ELECTRIC WHEELCHAIRSNXN20-2112025-08-13
06977027830764TANGHOMY NXN20-2082025-08-01
06977027830771TANGHOMYXFGW30-1072025-08-01
06977027830733JuswellNXN20-2082025-07-31
06977027830740JuswellNXN20-2112025-07-31
06977027830757JuswellNXN20-2052025-07-31
06977027830610WHEELCHAIR XFGW25-2032025-05-29
06977027830603ELECTRIC WHEELCHAIR NXN20-2082025-05-22
06977027830580ELECTRIC WHEELCHAIRSXFGW25-2032025-04-22

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