Donjoy

FDA UDI

Class I (US FDA UDI)

by Djo, Llc

Identity

Trade Name: DONJOY FDA UDI
Generic Name: Kinesiology ambulatory recorder FDA UDI
Device Name: X4 KNEE BRACE, LT, UNIV, BLK FDA UDI
Model / Reference: 11-4001-0-06000 FDA UDI
Description: X4 KNEE BRACE, LT, UNIV, BLK FDA UDI

Identifiers

Primary DI / UDI-DI: 00190446286974 FDA UDI
FDA Product Code: ITQ FDA UDI
IKK FDA UDI
GMDN Term: Kinesiology ambulatory recorder FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3475 FDA UDI
890.1925 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: Kinesiology ambulatory recorder

Donjoy by Djo, Llc — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Djo, Llc

Sources (1)

FDA UDI c68066c6-078d-42cf-b6b2-059e17f5794d 34 fields · synced Jun 8, 2026