FDA.reportPublic FDA data

Heartway Medical Products Co., Ltd

Primary DI
04719871230282
Brand
Heartway Medical Products Co., Ltd
Company
HEARTWAY MEDICAL PRODUCTS CO., LTD.
Model
P15
Published
2017-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K071005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071005000HEARTWAY LIGHTWEIGHT POWER CHAIR, P15Heartway Medical Products Co., Ltd.2007-05-22ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719871230282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871230282047198712302824719871230282

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, power-assisted, occupant-controlled, 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 manually propelled and steered by the rotation of both rear wheels by the occupant, and when needed, power from an electric motor replaces manual wheel rotation. The device may be disassembled or folded for transport. Typically, the user is a paraplegic or quadriparetic person who desires to manually propel himself as much as possible for the exercise. The power assist feature is enabled to climb inclines, for extended distance travel, or when the user fatigues.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657488735
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
04719871230145Heartway Medical Products Co., LtdS112017-01-23
04719871230152Heartway Medical Products Co., LtdPF72017-01-23
04719871230190Heartway Medical Products Co., LtdS192016-09-05
04719871230343Heartway Medical Products Co., LtdPF22017-01-23
04719871230350Heartway Medical Products Co., LtdPF32017-01-23
04719871230367Heartway Medical Products Co., LtdPF62017-01-23
04719871230374Heartway Medical Products Co., LtdPT72017-01-23
04719871230381Heartway Medical Products Co., LtdS122017-01-23
04719871230398Heartway Medical Products Co., LtdS152017-01-23
04719871230404Heartway Medical Products Co., LtdS162017-01-23
04719871230411Heartway Medical Products Co., LtdS172017-01-23
04719871230428Heartway Medical Products Co., LtdS332017-01-23
04719871230435Heartway Medical Products Co., LtdS342017-01-23
04719871230442Heartway Medical Products Co., LtdS82017-01-23
04719871230459Heartway Medical Products Co., LtdS92017-01-23
04719871230015Heartway Medical Products Co., Ltd HP62017-01-23
04719871230060Heartway Medical Products Co., LtdP16RT 2017-01-23
04719871230107Heartway Medical Products Co., LtdP252017-01-23
04719871230251Heartway Medical Products Co., LtdHP42017-01-23
04719871230299Heartway Medical Products Co., LtdP17RT 2017-01-23

Other Devices Sharing Product Codes#

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