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Compex

FDA UDI

Class II (US FDA UDI)

by Djo, Llc

Identity

Trade Name
COMPEX FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, single-use FDA UDI
Device Name
ELECTRODES DURA-STICK PIN 50X100MM RECT 2/PK FDA UDI
Model / Reference
6250800 FDA UDI
Description
ELECTRODES DURA-STICK PIN 50X100MM RECT 2/PK FDA UDI

Identifiers

Primary DI / UDI-DI
00888912000420 FDA UDI
510(k) Number
K132422 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
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

No

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Transcutaneous electrical stimulation electrode, single-use

Compex by Djo, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous electrical stimulation electrode, single-use.

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Djo, Llc

Sources (1)

  • FDA UDI 96ead3ca-4032-4933-8a75-343b21f68ae1 34 fields · synced May 30, 2026