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Emc Evolution

FDA UDI

Class II (US FDA UDI)

by Emc Evolution

Identity

Trade Name
EMC EVOLUTION FDA UDI
Generic Name
Perineal orifice incontinence-control electrical stimulation system FDA UDI
Model / Reference
112-B0-1-S FDA UDI

Identifiers

Primary DI / UDI-DI
03760265490394 FDA UDI
510(k) Number
K990041 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Perineal orifice incontinence-control electrical stimulation system

Emc Evolution by Emc Evolution — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K990041 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Emc Evolution

Sources (1)

  • FDA UDI ab08e2c7-dcc2-4dac-bc11-23be53ce6b0c 33 fields · synced May 29, 2026