Tenscare

Basic Information

• Brand Name: Tenscare
• Primary DI: 05033435134045
• Version / Model: TENS One
• Catalog Number: K-TENSONE
• Company Name: TENSCARE LIMITED
• Labeler DUNS: 569403736
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-05
• Public Version: 2
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: 9bea6bcf-26ec-4970-bb20-2c9f1c425652

Device Description

TENS One is a TENS device which is commonly used to provide relief from pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. It has 3 treatment modes and is designed to be easy to use, with analog-style rotary intensity controls, digital mode selection and display, open circuit detection and keypad cover. It uses standard AA batteries and self-adhesive electrode pads. Garment glove and sock electrodes are available as optional extras.

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: Yes
• 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
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	05033435134045	GS1

Customer Contacts

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