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Elitone URGE

FDA UDI

Class II (US FDA UDI)

by Elidah, Inc.

Identity

Trade Name
Elitone URGE FDA UDI
Generic Name
Transcutaneous incontinence-control electrical stimulator FDA UDI
Device Name
Elitone URGE Therapy Kit, includes 1x Elitone URGE (00851096008100) and 2x Elitone GelPad packs (00851096008032) FDA UDI
Model / Reference
EK-1019 FDA UDI
Description
Elitone URGE Therapy Kit, includes 1x Elitone URGE (00851096008100) and 2x Elitone GelPad packs (00851096008032) FDA UDI

Identifiers

Primary DI / UDI-DI
00851096008117 FDA UDI
FDA Product Code
QAJ FDA UDI
GMDN Term
Transcutaneous incontinence-control electrical stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5330 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

Yes

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Transcutaneous incontinence-control electrical stimulator

Elitone URGE by Elidah, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous incontinence-control electrical stimulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elidah, Inc.

Sources (1)

  • FDA UDI a1636e51-ebf5-4926-b5b0-e82c118c9710 33 fields · synced May 30, 2026