Innovo

FDA UDI

Class II (US FDA UDI)

by Atlantic Therapeutics, Ltd.

Identity

Trade Name: INNOVO FDA UDI
Generic Name: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Device Name: The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females. FDA UDI
Model / Reference: 208 FDA UDI
Description: The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females. FDA UDI

Identifiers

Catalog Number: 1500-0818 FDA UDI
Primary DI / UDI-DI: 15391533470517 FDA UDI
510(k) Number: DEN170049 FDA UDI
K192357 FDA UDI
FDA Product Code: QAJ FDA UDI
GMDN Term: Physical therapy transcutaneous neuromuscular electrical stimulation system 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system Electrode conductive medium

Innovo by Atlantic Therapeutics, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Atlantic Therapeutics, Ltd.

Sources (1)

FDA UDI 8902a442-6773-481c-8774-e9cecd6cd8f6 35 fields · synced May 30, 2026