FDA.reportPublic FDA data

Heartway Medical Products Co., Ltd

Primary DI
04719871230497
Brand
Heartway Medical Products Co., Ltd
Company
HEARTWAY MEDICAL PRODUCTS CO., LTD.
Model
P23
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
K100327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100327000HEARTWAY POWER CHAIR, P23Heartway Medical Products Co., Ltd.2010-03-22ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719871230497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871230497047198712304974719871230497

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
04719871230282Heartway Medical Products Co., LtdP152017-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436557351272BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351289BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351296BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351302BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351319BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351326BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351333BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351340BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351357BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351364BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351371BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351388BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351432BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351449BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351456BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351463BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351470BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351487BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351494BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351500BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351517BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351524BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351531BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351548BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351593BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351609BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351616BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351623BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351630BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351647BatecBATEC MOBILITY SL.ITI2026-07-29