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ActivaTek Ionto4 Butterfly

FDA UDI

Class II (US FDA UDI)

by North Coast Medical, Inc.

Identity

Trade Name
ActivaTek Ionto4 Butterfly FDA UDI
Generic Name
Multi-modality electrotherapy system FDA UDI
Device Name
ActivaTek Ionto4 Butterfly (12) FDA UDI
Model / Reference
NC89378 FDA UDI
Description
ActivaTek Ionto4 Butterfly (12) FDA UDI

Identifiers

Catalog Number
4511 FDA UDI
Primary DI / UDI-DI
10768627016312 FDA UDI
FDA Product Code
EGJ FDA UDI
GMDN Term
Multi-modality electrotherapy system 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

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-modality electrotherapy system

ActivaTek Ionto4 Butterfly by North Coast Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality electrotherapy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
North Coast Medical, Inc.

Sources (1)

  • FDA UDI b895cd61-b3bb-457f-bd98-0bf3a1db2abd 36 fields · synced Jun 8, 2026