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Compex

FDA UDI

Class II (US FDA UDI)

by Djo, Llc

Identity

Trade Name
COMPEX FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
COMPEX TENS/HEAT KNEE WRAP KIT S/M FDA UDI
Model / Reference
11-2144-2 FDA UDI
Description
COMPEX TENS/HEAT KNEE WRAP KIT S/M FDA UDI

Identifiers

Primary DI / UDI-DI
00190446287056 FDA UDI
FDA Product Code
IRT FDA UDI
NUH FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5740 FDA UDI
882.5890 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

Yes

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

Category: Analgesic transcutaneous electrical nerve stimulation system

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

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Djo, Llc

Sources (1)

  • FDA UDI e78d4c47-e199-407f-85b8-fad2eb9e3a12 33 fields · synced May 30, 2026