IontoPatch

FDA UDI

Class II (US FDA UDI)

by LTS Therapy Systems, LLC

Identity

Trade Name: IontoPatch FDA UDI
Generic Name: Drug-delivery iontophoresis patch FDA UDI
Device Name: The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis. FDA UDI
Model / Reference: STAT FDA UDI
Description: The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis. FDA UDI

Identifiers

Primary DI / UDI-DI: 10815611020005 FDA UDI
510(k) Number: K992708 FDA UDI
FDA Product Code: EGJ FDA UDI
GMDN Term: Drug-delivery iontophoresis patch FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5525 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Drug-delivery iontophoresis patch

IontoPatch by LTS Therapy Systems, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Drug-delivery iontophoresis patch.

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ActivaPatch IontoGo 12.0 Sample — ACTIVATEK INC. · Class II
Trivarion Medium & Butterfly Sample — ACTIVATEK INC. · Class II
PERFORMA — Performance Health Supply, LLC · Class II

Cleared under the same submission

K992708 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: LTS Therapy Systems, LLC

Sources (1)

FDA UDI 44846405-e60a-4500-9480-36a613a41346 35 fields · synced Jun 6, 2026