CHATTANOOGA

GUDID 00888912567152

VITALSTIM PLUS REFERENCE EMG ELECTRODE w/ IFU

DJO, LLC

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00888912567152
• NIH Device Record Key: de0641ef-679f-4db3-9c2e-9cdc8bc05773
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHATTANOOGA
• Version Model Number: 13-8082
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888912567152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092546

FDA Product Code

• GXY: ELECTRODE, CUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [CHATTANOOGA]

• 00190446322108: UDI GUDID Test Part
• 00190446305149: FLUIDTHERAPY DOUBLE EXTREMITY
• 00190446305132: FLUIDOTHERAPY FT110 SINGLE
• 00190446238225: I-BRESIS PATCH BOX OF 6
• 00190446238201: I-BRESIS, CHARGING STATION
• 00190446238188: I-BRESIS, CONTROLLER
• 00190446201946: TTET TRACTION ACCESSORY PACKAGE - BURGANDY
• 00190446188544: 4 ELASTIC STRAPS CHATANOOGA FOR WIRELESS
• 00190446165279: NEO MODULE ULTRASOUND
• 00190446164104: KIT THIGH CONDUCTIVE GARMENT
• 00190446164098: KIT SHOULDER CONDUCTIVE GARMENT
• 00190446164081: KIT KNEE CONDUCTIVE GARMENT
• 00190446163985: VITALSTIM PLUS ELECTROTHERAPY SYSTEM
• 00190446153306: STIMGEL GARMENT ELECTRODES, 4 EA SQUARE 2"
• 00190446153290: STIMGEL GARMENT ELECTRODES, 1 EA 6 X 3.5" & 2 EA 2.75 X 4"
• 00190446145028: SELLABLE CHATT REVOLUTION WIRELESS STIMULATION MODULE
• 00190446145011: SELLABLE CHATT REVOLUTION WIRELESS REMOTE CONTROL
• 00190446143796: CHATTANOOGA PRIMERA GARMENT CONNECTOR
• 00190446136897: PRIMERA TENS/NMES, OVER THE COUNTER
• 00888912294003: APPLICATOR SINGLE 850NM 200MW
• 00888912293990: APPLICATOR SINGLE 850NM 100MW
• 00888912293891: APPLICATOR 13CLS 3X200MW 715MW
• 00888912293884: APPLICATOR 19CLS LED 325MW
• 00888912293877: APPLICATOR 13CLSX100MW 415MW
• 00888912293860: APPLICATOR 13CLS 3X50MW 265MW
• 00888912293853: APPLICATOR 9CLS 5X200MW 1040MW
• 00888912293846: APPLICATOR 9CLS 5X100MW 540MW
• 00888912293839: APPLICATOR 9CLS 5X50MW 290MW
• 00888912293808: APPLICATOR 33CLS LED 565MW
• 00888912293792: APPLICATOR 33CLS 5X200MW 1440MW
• 00888912293785: APPLICATOR 33CLS 5X100MW 940MW
• 00888912293778: APPLICATOR SINGLE 820NM 300MW
• 00888912293761: APPLICATOR 850NM 150MW LASER
• 00888912293754: APPLICATOR SINGLE 850NM 40MW
• 00888912293747: APPLICATOR 33CLS 5X50MW 690MW
• 00888912293693: APPLICATOR SINGLE 670NM 10MW
• 00888912585231: SET CHATT REVOLUTION WIRELESS EN SP US PLUG
• 00888912572439: Kit, Chatt Element
• 00888912567176: VITALSTIM PLUS HAND SWITCH
• 00888912374088: INTELECT TENS DIG PKG INT'L
• 00888912374064: INTELECT NMES DIG PKG INT'L
• 00888912374057: INTELECT NMES PORT PKG INT'L
• 00888912374040: INTELECT TENS ECO PKG INT'L
• 00888912374019: INTELECT DIGITAL NMES UNIT
• 00888912373999: INTELECT NMES UNIT
• 00888912373951: INTELECT BASIC TENS UNIT
• 00888912373852: PRIMERA TENS/NMES, KIT
• 00888912373838: INTELECT TENS INTERNATIONAL
• 00888912372824: INTELECT DIGITAL HIGH VOLT STI MULATOR
• 00888912357326: KIT, VITALSTIM SMALL PACKAGE