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InTone® by Viveve

FDA UDI

Class II (US FDA UDI)

by Incontrol Medical, Llc

Identity

Trade Name
InTone® by Viveve FDA UDI
Generic Name
Perineal orifice incontinence-control electrical stimulation system probe, reusable FDA UDI
Device Name
InTone by Viveve FDA UDI
Model / Reference
2000001A4 FDA UDI
Description
InTone by Viveve FDA UDI

Identifiers

Catalog Number
2000001A4 FDA UDI
Primary DI / UDI-DI
00851508007073 FDA UDI
FDA Product Code
HIR FDA UDI
KPI FDA UDI
GMDN Term
Perineal orifice incontinence-control electrical stimulation system probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1425 FDA UDI
876.5320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 12 Inch FDA UDI

Category: Perineal orifice incontinence-control electrical stimulation system probe, reusable

InTone® by Viveve by Incontrol Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Perineal orifice incontinence-control electrical stimulation system probe, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Incontrol Medical, Llc

Sources (1)

  • FDA UDI a9c9781b-a188-4b7e-95d7-331db40e5ae2 37 fields · synced May 30, 2026