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EmbaGYN

FDA UDI

Class II (US FDA UDI)

by Tenscare Limited

Identity

Trade Name
EmbaGYN FDA UDI
Generic Name
Perineal orifice incontinence-control electrical stimulation system FDA UDI
Device Name
EmbaGYN Pelvic Floor Exerciser is a portable, battery operated electrical muscle stimulator. EmbaGYN is indicated for the rehabilitation and strengthening of weak pelvic floor muscles in the treatment of stress, urge, and mixed urinary incontinence. It is designed to be extremely easy to use, and is intended for daily use by the patient in their own home. The EmbaGYN is supplied with a Liberty vaginal electrode that may not be sterilised and is intended for single patient use. FDA UDI
Model / Reference
itouch Sure FDA UDI
Description
EmbaGYN Pelvic Floor Exerciser is a portable, battery operated electrical muscle stimulator. EmbaGYN is indicated for the rehabilitation and strengthening of weak pelvic floor muscles in the treatment of stress, urge, and mixed urinary incontinence. It is designed to be extremely easy to use, and is intended for daily use by the patient in their own home. The EmbaGYN is supplied with a Liberty vaginal electrode that may not be sterilised and is intended for single patient use. FDA UDI

Identifiers

Catalog Number
K-EMBAGYN FDA UDI
Primary DI / UDI-DI
05033435132171 FDA UDI
FDA Product Code
KPI FDA UDI
GMDN Term
Perineal orifice incontinence-control electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Perineal orifice incontinence-control electrical stimulation system

EmbaGYN by Tenscare Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tenscare Limited

Sources (1)

  • FDA UDI 5a5e9dee-e75a-457f-a8d3-d661e96dba8e 34 fields · synced May 30, 2026