FDA.reportPublic FDA data

Freedomchair

Primary DI
06971086400326
Brand
Freedomchair
Company
Kunshan Aoshida Electric Technology Co., Ltd
Model
A12S
Catalog number
DYW50-A12S
Device description
An power wheelchair consists of a frame, wheels, seat, armrests, battery, motor, and controller.
Published
2025-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K163204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163204000A08 Power wheelchairKunshan Aoshida Electric Technology Co., Ltd.2017-05-05ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971086400326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971086400326069710864003266971086400326

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
543600297
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
06971086400227FreedomchairA12DYW50-A122025-07-09
06971086400036FreedomchairT3DYW50-A052017-10-16
06971086400067FreedomchairA06DYW50-A062017-11-02
06971086400074FreedomchairA07DYW50-A072017-11-02
06971086400081FreedomchairA08DYW50-A082017-11-02
06971086400098FreedomchairA09DYW50-A092017-11-02
06971086400104FreedomchairA10DYW50-A102017-11-24
06971086400111FreedomchairS1S12017-11-24
06971086400135FreedomchairA13DYW50-A132018-01-08
06971086400166FreedomchairA06LDYW50-A06L2018-01-08
06971086400128FREEDOMCHAIRS22023-01-10
06971086400210FREEDOMCHAIRA112023-01-10
06971086400289FREEDOMCHAIRDE082023-01-10
06971086400388FREEDOMCHAIRDE08L2023-01-10
06971086400180FREEDOMCHAIRA08L2022-11-12
06971086400012FREED MCHVIR082017-07-03
06971086400029FREED MCHVIR062017-10-16
06971086400043FREED MCHVIR062017-10-16
06971086400050FREED MCHVIR0802017-11-02
06971086400142FREED MCHVIR062018-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973175531430MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-30
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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