INCONTROL MEDICAL, LLC

INCONTROL MEDICAL, LLC

Address:3225 Gateway Rd,Brookfield,WI,53045,US

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Filters

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) (9) PERINEOMETER (HIR) (3) Stimulator, Electrical, Non-Implantable, For Incontinence (KPI) (1)

Premarket Exempt

No

Clear

InTone® - 00851508007004 Catalog Number : 2000001A1

Device Description : InTone

Device Class : 2

Duns Number: 052247990

Premarket Exempt : No

Product Code : HIR, KPI

Prescription Use : Yes

Device Count : 1

InTone®MV - 00851508007011 Catalog Number : 5000000A1

Device Description : InToneMV

Device Class : 2

Duns Number: 052247990

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Apex® - 00851508007028 Catalog Number : 3000000A1

Device Description : Apex

Device Class : 2

Duns Number: 052247990

Premarket Exempt : No

Product Code : KPI

Prescription Use : No

Device Count : 1

Apex®M - 00851508007035 Catalog Number : 3100000A1

Device Description : ApexM

Device Class : 2

Duns Number: 052247990

Premarket Exempt : No

Product Code : KPI

Prescription Use : No

Device Count : 1

InTone® NASP - 00851508007042 Catalog Number : 2000001A1-NASP

Device Description : InTone NASP

Device Class : 2

Duns Number: 052247990

Premarket Exempt : No

Product Code : HIR, KPI

Prescription Use : Yes

Device Count : 1

InTone®MV NASP - 00851508007059 Catalog Number : 5000000A1-NASP

Device Description : InToneMV-NASP

Device Class : 2

Duns Number: 052247990

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

InTone® by Viveve - 00851508007073 Catalog Number : 2000001A4

Device Description : InTone by Viveve

Device Class : 2

Duns Number: 052247990

Premarket Exempt : No

Product Code : HIR, KPI

Prescription Use : Yes

Device Count : 1

InTone®MV by Viveve - 00851508007080 Catalog Number : 5000000A4

Device Description : InToneMV by Viveve

Device Class : 2

Duns Number: 052247990

Premarket Exempt : No

Product Code : KPI

Prescription Use : Yes

Device Count : 1

Apex®M by Viveve - 00851508007097 Catalog Number : 3100000A4

Device Description : ApexM by Viveve

Device Class : 2

Duns Number: 052247990

Premarket Exempt : No

Product Code : KPI

Prescription Use : No

Device Count : 1

Attain - 00851508007103 Catalog Number : 3200000A1

Device Description : Attain

Device Class : 2

Duns Number: 052247990

Premarket Exempt : No

Product Code : KPI

Prescription Use : No

Device Count : 1

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