POLE ELECTRODE PEN TYPE

Basic Information

• Brand Name: POLE ELECTRODE PEN TYPE
• Primary DI: 14897076721136
• Version / Model: A4.Pen
• Company Name: TENS PLUS INDUSTRIAL COMPANY
• Labeler DUNS: 663211978
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-14
• Public Version: 1
• Public Version Date: 2022-11-22
• Public Version Status: New
• Public Device Record Key: 73e7e9bb-fd2f-4024-9b6b-dd39982c2043

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
KNM	Device, Pressure Applying	Physical Medicine	890.5765	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34009	External manual massager, clinical	A manual (non-powered) device designed to apply external massage to a patient, by the patient, staff, or a therapist in a hospital, institution, or therapeutic treatment situation. It is intended to stimulate/massage body muscles to provide a therapeutic effect. It is typically designed to be held in the hands and is available in a variety of configurations and materials, e.g., plastic, wood, ceramics. It is available in a variety of sizes and shapes and may be a one-piece device or have interchangeable massaging components (e.g., roller heads or pads), and have a variety of massage surfaces (e.g., points, ribs, smooth). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14897076721136	GS1