Dual-Channel Digital T.E.N.S.

Basic Information

• Brand Name: Dual-Channel Digital T.E.N.S.
• Primary DI: 10660584000413
• Version / Model: DGDIGT
• Company Name: Dynatronics Corporation
• Labeler DUNS: 113399125
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-10-31
• Public Version Status: Update
• Public Device Record Key: 3b73bdc5-dbd4-403f-95a4-2b548bcdc249
• Distribution End Date: 2023-10-31

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• 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
IPF	Stimulator, Muscle, Powered	Physical Medicine	890.5850	2
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	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	10660584000413	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	61.5	Millimeter
Length	108	Millimeter
Height	25	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 140 Degrees Fahrenheit