Identity
- Trade Name
- COMPEX FDA UDI
- Generic Name
- Interferential electrical stimulation system FDA UDI
- Device Name
- COMPEX SPORT ELITE 3.0 FDA UDI
- Model / Reference
- CX192WI01 FDA UDI
- Description
- COMPEX SPORT ELITE 3.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190446337348 FDA UDI
- FDA Product Code
- NGX FDA UDI
- GMDN Term
- Interferential electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Interferential electrical stimulation system
Compex by Djo, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Interferential electrical stimulation system.
- Hako-Med — HAKO-MED Herstellung + Vertrieb von medizinisch-technischen Geräten G.m.b.H. · Class II
- VECTTOR Therapy System — ALAN NEUROMEDICAL TECHNOLOGIES, L.L.C. · Class II
- VQ OrthoCare — Vision Quest Industries Incorporated · Class II
- NexWave — ZYNEX MEDICAL, INC. · Class II
- Hakomed — HAKOMED ASIA COMPANY LIMITED · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
- Liberty Multi-Mode Stimulator — LIBERTY MEDICAL SOLUTIONS, LLC · Class II
- Hako-Med — HAKO-MED Herstellung + Vertrieb von medizinisch-technischen Geräten G.m.b.H. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Djo, Llc
Sources (1)
- FDA UDI 009c33cf-cc07-484f-87f5-4876d5b66fbb 33 fields · synced May 30, 2026