Hakomed

FDA UDI

Class II (US FDA UDI)

by Hakomed Asia Company Limited

Identity

Trade Name: Hakomed FDA UDI
Generic Name: Interferential electrical stimulation system FDA UDI
Model / Reference: PROElecDT HT Regenerator FDA UDI

Identifiers

Primary DI / UDI-DI: 00860012846917 FDA UDI
FDA Product Code: LIH FDA UDI
IPF FDA UDI
GMDN Term: Interferential electrical stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5890 FDA UDI
890.5850 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Interferential electrical stimulation system

Hakomed by Hakomed Asia Company Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Hakomed Asia Company Limited

Sources (1)

FDA UDI a1b86c57-1928-47a9-abbc-269c153997f9 33 fields · synced Jun 1, 2026