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Carbon-Rubber Electrodes (8" x 3")

FDA UDI

Class II (US FDA UDI)

by Electromedical Technologies, Inc

Identity

Trade Name
Carbon-Rubber Electrodes (8" x 3") FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, single-use FDA UDI
Model / Reference
0 FDA UDI

Identifiers

Primary DI / UDI-DI
B243PSRCR2102 FDA UDI
510(k) Number
K002227 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Transcutaneous electrical stimulation electrode, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Carbon-Rubber Electrodes (8" x 3") by Electromedical Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K002227 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Electromedical Technologies, Inc

Sources (1)

  • FDA UDI 00d68f5f-3227-442f-a1c9-710769489595 34 fields · synced Jun 8, 2026