actiTENS

Basic Information

• Brand Name: actiTENS
• Primary DI: B786SBM1AB0110
• Version / Model: actiTENS self-adhesive strips
• Catalog Number: SBM1AB011
• Company Name: SUBLIMED
• Labeler DUNS: 267525498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-24
• Public Version: 1
• Public Version Date: 2024-05-02
• Public Version Status: New
• Public Device Record Key: 74a6e0cd-ed40-45a9-88dd-bf0e22165e30

Device Description

The actiTENS electric impulse generator can be held on the patient's body thanks to a self-adhesive trip made of a silicone-based adhesive. The self-adhesive strip is intended to be placed on any part of the body but not on injured or irritated skin. The purpose of the self-adhesive strip is to maintain the actiTENS electric impulse generator near the part of the body which the patient wants to stimulate.

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	890.5850	2
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	882.5890	2
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	2
IPF	Stimulator, Muscle, Powered	Physical Medicine	890.5850	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	B786SBM1AB0110	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K202159	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius