FDA.reportPublic FDA data

Freedomchair

Primary DI
06971086400081
Brand
Freedomchair
Company
Kunshan Aoshida Electric Technology Co., Ltd
Model
A08
Catalog number
DYW50-A08
Device description
An power wheelchair consists of a frame, wheels, seat, armrests, battery, motor, and controller.
Published
2017-11-02
Public version status
Update
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
06971086400081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971086400081069710864000816971086400081

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, attendant-controlled, powered-steering, non-collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction is performed by an attendant. The device cannot be folded or readily dismantled for transport.

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
06971086400326FreedomchairA12SDYW50-A12S2025-07-09
06971086400036FreedomchairT3DYW50-A052017-10-16
06971086400067FreedomchairA06DYW50-A062017-11-02
06971086400074FreedomchairA07DYW50-A072017-11-02
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