FDA UDI In Commercial Distribution 🇺🇸 United States

COMPEX

DI: 00190446262183 · Model: 506011TENS · DJO, LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
COMPEX
Primary DI
00190446262183
Version / Model
506011TENS
Company Name
DJO, LLC
Labeler DUNS
081840873
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-11-02
Public Version
8
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
ef014c16-adbe-425b-9a74-ed32b8d68083

Device Description

SET COMPEX PERFORMANCE US 2.0

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NGX STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
NYN Stimulator, electrical, transcutaneous, for arthritis
NUH STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

GMDN Terms

Code Name
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

Identifiers

Type ID
Primary 00190446262183