FDA.reportPublic FDA data

SOUNDFUSE

Primary DI
14895262504259
Brand
SOUNDFUSE
Company
HongKong Pishon Medical Equipment Co., Limited
Model
UR410-RD
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14895262504259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1489526250425914895262504259

GMDN Terms#

Term, Definition table
TermDefinition
Handgrip disability-assistive walker, non-powered, non-foldableA non-powered, all- or partially-wheeled mobility aid in the form of a waist- or trunk-high, non-foldable framework with handgrips or hand-held frame and three or four legs, designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it might be used for rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials in the shape of a mobile support structure which the patient holds and pushes in front of them as they walk. It is non-foldable and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.

Regulatory Flags#

DUNS number
989225520
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14895262504266SOUNDFUSEUR410-CP2026-04-22
14895262504273SOUNDFUSEUR410-BL2026-04-22
14895262504280SOUNDFUSEUR410-BK2026-04-22
14895262504693HOMLANDR16-RR2026-04-22
14895262504709HOMLANDR16-RD2026-04-22
14895262504716HOMLANDR16-PU2026-04-22
14895262504730HOMLANDR16-BL2026-04-22
14895262521362HOMLANDC7-SL2026-04-22
14895262521829SOUNDFUSEUC7-SL2026-04-22
24895262504324SOUNDFUSEUR310-BK2026-04-22
24895262521048HOMLANDBC42026-04-22
24895262521390HOMLANDC9-GR2026-04-22
24895262521574HOMLANDSHC202026-04-22
24895262521727SOUNDFUSEUBS0-GR2026-04-22
34895262521304HOMLANDC42026-04-22
34895262521519HOMLANDH3-BK2026-04-22
34895262521670HOMLANDTRB102026-04-22
34895262521779SOUNDFUSEUC1-GR2026-04-22
44895262521578HOMLANDSHC202026-04-22
44895262521677HOMLANDTRB102026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977176610248BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610255BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610262BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610279BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610286BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610293BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610309BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610316BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610323BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610330BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610347BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610354BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610361BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610378BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610385BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610392BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610408BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610415BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610422BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610439BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610446BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610453BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610460BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610477BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610484BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610491BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610507BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610514BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610521BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610538BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25