WiTouch

Basic Information

• Brand Name: WiTouch
• Primary DI: 00853096004014
• Version / Model: 11.1510
• Catalog Number: 11.1510
• Company Name: HOLLYWOG, LLC
• Labeler DUNS: 043450879
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 4
• Public Version Date: 2019-10-31
• Public Version Status: Update
• Public Device Record Key: 75829d70-4362-41c9-bd2e-79ca3172b977
• Distribution End Date: 2017-09-30

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35372	Analgesic transcutaneous electrical nerve stimulation system	An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853096004014	GS1
Package	00853096004243	GS1	box	1	Not in Commercial Distribution	2017-09-30
Package	00853096004335	GS1	case	6	Not in Commercial Distribution	2017-09-30

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	90	Millimeter
Width	191	Millimeter
Outer Diameter	18	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Store the device, remote control and gel pads in original packaging when not in use.
• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 KiloPascal