FDA.reportPublic FDA data

All Star Wheelchairs

Primary DI
06977027830795
Brand
All Star Wheelchairs
Company
Zhejiang Nysin Medical Co.,Ltd
Model
XFGW30-107
Published
2025-08-26
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
K212854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212854000Powered WheelchairZhejiang Qianxi Vehicle Co., Ltd.2022-01-10ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977027830795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977027830795069770278307956977027830795

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

Contacts#

Phone, Email table
PhoneEmail
17073624984heiko@gmirrmedia.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
06977027831099CHINFREANNXN20-2112026-06-23
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
06977027830832PORTOLA TECH LLCNXN20-2112025-10-15
06977027830825Call of OasisNXN20-2082025-09-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974842140160RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140177RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140504Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140566RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140580Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140641Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140665Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140726Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140740Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142102RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142119RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142126RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142140RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
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
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