WiTouch Pro 11.1500

GUDID 00853096004021

WiTouch brand over the counter transcutaneous electrical nerve simulator to be used for temporary relief of pain associated with sore and aching muscles in the back due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back associated with arthritis.

HOLLYWOG, LLC

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00853096004021
• NIH Device Record Key: 58de1340-d853-4539-a4c9-cdaecd72c155
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WiTouch Pro
• Version Model Number: 11.1500
• Catalog Number: 11.1500
• 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

• Width: 191 Millimeter
• Width: 191 Millimeter
• Width: 191 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853096004021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171599

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: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-07-10

Devices Manufactured by HOLLYWOG, LLC

• 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: 2019-10-23WiTouch brand over the counter transcutaneous electrical nerve simulator to be used for temporary relief of pain associated with sore and aching muscles in the back due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back associated with arthritis.
• 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