Home Care

FDA UDI

Class II (US FDA UDI)

by Home Care Technology Co., Ltd.

Identity

Trade Name: Home Care FDA UDI
Generic Name: Electrical probe/electrode conductive pad FDA UDI
Device Name: Transcutaneous electrical stimulation electrode FDA UDI
Model / Reference: FA4040 FDA UDI
Description: Transcutaneous electrical stimulation electrode FDA UDI

Identifiers

Primary DI / UDI-DI: 04719873684724 FDA UDI
510(k) Number: K022917 FDA UDI
FDA Product Code: GXY FDA UDI
GMDN Term: Electrical probe/electrode conductive pad 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrical probe/electrode conductive pad

Home Care by Home Care Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrical probe/electrode conductive pad.

Alpha-Stim Earclip Electrode Pad — Electromedical Products International, Inc. · Class III
Jiajian — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
TruDenta Earclip Electrode Pad — Electromedical Products International, Inc. · Class III
Everyway — EVERYWAY MEDICAL INSTRUMENTS CO., LTD. · Class II
Jiajian — Wuxi Jiajian Medical Instrument Co., Ltd. · Class II
CHATTANOOGA — DJO, LLC · Class I
Home Care — Home Care Technology Co., Ltd. · Class II
Home Care — Home Care Technology Co., Ltd. · Class II

Cleared under the same submission

K022917 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: Home Care Technology Co., Ltd.

Sources (1)

FDA UDI 45eb3b60-3c8a-4531-8054-f09f945de0a0 34 fields · synced May 30, 2026