WiTouch 11.1510

GUDID 00853096004014

WiTouch brand over the counter transcutaneous electrical nerve simulator for analgesic pain relief in the lower back

HOLLYWOG, LLC

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00853096004014
• NIH Device Record Key: 75829d70-4362-41c9-bd2e-79ca3172b977
• Commercial Distribution Discontinuation: 2017-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: WiTouch
• Version Model Number: 11.1510
• Catalog Number: 11.1510
• Company DUNS: 043450879
• Company Name: HOLLYWOG, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 4233057778
• Email: info@hollywog.com

Device Dimensions

• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter
• Outer Diameter: 18 Millimeter

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853096004014 [Primary]
GS1	00853096004243 [Package]; Package: box [1 Units]; Discontinued: 2017-09-30; Not in Commercial Distribution
GS1	00853096004335 [Package]; Contains: 00853096004243; Package: case [6 Units]; Discontinued: 2017-09-30; Not in Commercial Distribution

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-31
• Device Publish Date: 2016-09-20

Devices Manufactured by HOLLYWOG, LLC

• 00853096004014 - WiTouch: 2019-10-31WiTouch brand over the counter transcutaneous electrical nerve simulator for analgesic pain relief in the lower back
• 00853096004014 - WiTouch: 2019-10-31 WiTouch brand over the counter transcutaneous electrical nerve simulator for analgesic pain relief in the lower back
• 00853096004083 - Neubac: 2019-10-31 Neubac brand of over the counter transcutaneous electrical nerve stimulator for analgesic pain relief in the lower back.
• 10853096004158 - Modpod: 2019-10-31 Modpod brand powered, static/intermittent, mobile traction system
• 00853096004021 - WiTouch Pro: 2019-10-23 WiTouch brand over the counter transcutaneous electrical nerve simulator to be used for temporary relief of pain associated with