EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

Address:3 FL., NO. 5, LANE 155, SEC.3 BEISHEN RD.,NEW TAIPEI CITY,TW

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Electrical, Non-Implantable, For Incontinence (KPI) (8) Electrode, Cutaneous (GXY) (1) Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (1) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (1)

Premarket Exempt

Clear

Lifecare - 04719871183373 Catalog Number :

Device Description : Incontinence probePerineal orifice incontinence-control electrical stimulation s Incontinence probePerineal orifice incontinence-control electrical stimulation system electrode

Device Class : 2

Duns Number: 657383535

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Lifecare - 04719871183380 Catalog Number :

Device Description : Incontinence probePerineal orifice incontinence-control electrical stimulation s Incontinence probePerineal orifice incontinence-control electrical stimulation system electrode

Device Class : 2

Duns Number: 657383535

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Lifecare - 04719871183397 Catalog Number :

Device Description : Incontinence probePerineal orifice incontinence-control electrical stimulation s Incontinence probePerineal orifice incontinence-control electrical stimulation system electrode

Device Class : 2

Duns Number: 657383535

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Lifecare - 04719871183403 Catalog Number :

Device Description : Incontinence probePerineal orifice incontinence-control electrical stimulation s Incontinence probePerineal orifice incontinence-control electrical stimulation system electrode

Device Class : 2

Duns Number: 657383535

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Lifecare - 04719871183410 Catalog Number :

Device Description : Incontinence probePerineal orifice incontinence-control electrical stimulation s Incontinence probePerineal orifice incontinence-control electrical stimulation system electrode

Device Class : 2

Duns Number: 657383535

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Lifecare - 04719871183427 Catalog Number :

Device Description : Incontinence probePerineal orifice incontinence-control electrical stimulation s Incontinence probePerineal orifice incontinence-control electrical stimulation system electrode

Device Class : 2

Duns Number: 657383535

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Lifecare - 04719871183434 Catalog Number :

Device Description : Incontinence probePerineal orifice incontinence-control electrical stimulation s Incontinence probePerineal orifice incontinence-control electrical stimulation system electrode

Device Class : 2

Duns Number: 657383535

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Lifecare - 04719871183441 Catalog Number :

Device Description : Incontinence probePerineal orifice incontinence-control electrical stimulation s Incontinence probePerineal orifice incontinence-control electrical stimulation system electrode

Device Class : 2

Duns Number: 657383535

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Everyway - 04719871183458 Catalog Number :

Device Description : Electrical Muscel Stimulator (EMS)

Device Class : 2

Duns Number: 657383535

Premarket Exempt : No

Product Code : NUH, NGX

Prescription Use : No

Device Count : 1

Everyway - 04719871183489 Catalog Number :

Device Description : Electrode conductive padA small, non-sterile device designed to facilitate elect Electrode conductive padA small, non-sterile device designed to facilitate electrical conduction between an electrical stimulation electrode and the skin. It is typically contoured to fit on a particular type of electrode and is made of an absorbent material (e.g., felt) that may be soaked in a conduction fluid.

Device Class : 2

Duns Number: 657383535

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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