COMPEX

GUDID 00190446253310

COMPEX WIRELESS USA 2.0 TENS COMPLETE SET

DJO, LLC

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00190446253310
• NIH Device Record Key: 8510f4e7-2e44-417e-a470-1114e58b5214
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPEX
• Version Model Number: 2540660-17
• Company DUNS: 081840873
• Company Name: DJO, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190446253310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170903

FDA Product Code

• NGX: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-11-30

On-Brand Devices [COMPEX]

• 00190446287063: COMPEX TENS/HEAT KNEE WRAP KIT L/XL
• 00190446287056: COMPEX TENS/HEAT KNEE WRAP KIT S/M
• 00190446287049: COMPEX TENS/HEAT BACK WRAP KIT L/XL
• 00190446287032: COMPEX TENS/HEAT BACK WRAP KIT S/M
• 00190446262190: SET COMPEX EDGE US 2.0
• 00190446262183: SET COMPEX PERFORMANCE US 2.0
• 00190446262176: SET COMPEX SPORT ELITE US 2.0
• 00190446255642: PERFORMANCE ELECTRODES 2X4 (inches), COMPEX RECT, 1 SNAP,
• 00190446254058: PERFORMANCE ELECTRODES, 2X4 (inches) SINGLE SNAP 5PK, COMPE
• 00190446253488: PERFORMANCE ELECTRODES, 2X4 (inches) DUAL SNAP 5PK, COMPEX,
• 00190446253471: PERFORMANCE ELECTRODES, 2X2 (inches) 5PK, COMPEX, WHITE
• 00190446253310: COMPEX WIRELESS USA 2.0 TENS COMPLETE SET
• 00190446244462: PERFORMANCE ELECTRODES 2X2 (inches), COMPEX, WHITE
• 00190446244455: PERFORMANCE ELECTRODES 2X4 (inches), DUAL SNAP, COMPEX, WHIT
• 00190446241201: SET COMPEX EDGE US17
• 00190446241195: SET COMPEX PERFORMANCE US17
• 00190446241171: SET COMPEX SPORT ELITE US17
• 00190446189725: PERFORMANCE ELECTRODES 2X4 (inches) DUAL SNAP 5PK, COMPEX,
• 00190446189664: PERFORMANCE ELECTRODES 2X2 (inches) 5PK, COMPEX, BLACK
• 00190446131823: SERVICE PART WIRELESS ALL BLACK MODULE
• 00888912290463: COMPEX WIRELESS USA COMPLETE SET
• 00888912217958: COMPEX SPORT
• 00888912000284: COMPEX EDGE US
• 00888912000277: COMPEX PERFORMANCE US
• 00888912000260: SPORT ELITE
• 00888912359481: SET 4 CABLES 6P / SNAPS
• 00888912341202: DURA-STICK+ SNAP 5X10CM RECT. 1 SNAP 2/PK
• 00888912341141: PERFORMANCE 5X10CM RECT. 2/PK
• 00888912341134: PERFORMANCE 5CM SQ 4/PK
• 00888912221016: PERFORMANCE ELECTRODES 2X4INCHES, COMPEX RECTANGULAR 1 SNAP
• 00888912043533: PERFORMANCE ELECTRODES 2"X2", COMPEX
• 00888912000437: STIMTRODE 50X50MM 4/PK
• 00888912000420: STIMTRODE 50X100MM 2/PK
• 00888912000413: PERFORMANCE ELECTRODES 2"X4", COMPEX
• 00888912000253: PERFORMANCE SNAP 5X10CM RECT. 2/PK
• 00888912000246: PERFORMANCE SNAP 5CM SQ 4/PK
• 00190446337362: COMPEX EDGE 3.0
• 00190446337355: COMPEX PERFORMANCE 3.0
• 00190446337348: COMPEX SPORT ELITE 3.0
• 00190446662457: COMPEX FUSE LIDOCAINE
• 00190446334088: COMPEX MINI
• 00190446301776: COMPEX TENS/HEAT KNEE WRAP + DEVICE, S/M
• 00190446301752: COMPEX TENS/HEAT BACK WRAP + DEVICE, S/M
• 00190446301745: COMPEX TENS/HEAT BACK WRAP + DEVICE, L,XL
• 00190446260011: COMPEX TENS/ HEAT KNEE WRAP, L/XL
• 00190446260004: COMPEX TENS/ HEAT KNEE WRAP, S/M
• 00190446771517: COMPEX TENS/ HEAT KNEE WRAP S/M
• 00190446259954: COMPEX TENS/ HEAT CONTROL UNIT FOR BRACING
• 00190446303183: COMPEX LT