Alpha

FDA UDI

Class II (US FDA UDI)

by WillowWood Global LLC

Identity

Trade Name: Alpha FDA UDI
Generic Name: Analytical non-scalp cutaneous electrode FDA UDI
Device Name: Alpha Control Liner System Kit Extra Small, 20 cm Leads FDA UDI
Model / Reference: ACLS-049-X20 FDA UDI
Description: Alpha Control Liner System Kit Extra Small, 20 cm Leads FDA UDI

Identifiers

Catalog Number: ACLS-049-X20 FDA UDI
Primary DI / UDI-DI: 00194711116089 FDA UDI
510(k) Number: K223738 FDA UDI
FDA Product Code: GXY FDA UDI
GMDN Term: Analytical non-scalp cutaneous electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1320 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Analytical non-scalp cutaneous electrode

The Alpha Control Liner System Kit Extra Small, 20 cm Leads is a non-invasive neurology device used for electrophysiological recording and monitoring. This single-patient device consists of a small rectangular tab or cup/disk with a conductive surface that may include a lead wire, designed to be attached to the skin surface outside of the hair line.

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Cleared under the same submission

K223738 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: WillowWood Global LLC

Sources (1)

FDA UDI 104cf75d-62db-47be-88d7-99338b91022d 36 fields · synced Jun 29, 2026