iReliev

DI: 00853635002426 · Model: ET-5050 · EXCELHEALTH, INC.

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

Basic Information

Brand Name: iReliev
Primary DI: 00853635002426
Version / Model: ET-5050
Catalog Number: ET-5050
Company Name: EXCELHEALTH, INC.
Labeler DUNS: 079213529
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-01-12
Public Version: 6
Public Version Date: 2021-02-19
Public Version Status: Update
Public Device Record Key: d51f7372-d7f5-4f89-9abb-ac62305048b0

Device Description

iReliev PlayMakar Therapeutic Wearable System

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: Yes
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: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	882.5890	2
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	882.5890	2
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	890.5850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35995	Transcutaneous electrical stimulation electrode, single-use	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.	No	Active
46463	Arthritis TENS system	An assembly of battery-powered devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneously). It typically consists of an external electric current generator and electrodes that are placed on the skin near a joint(s) to provide the electrical stimulus to the painful area. 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 routine home-use to treat symptoms of rheumatoid arthritis (RA) of the hands and osteoarthritis of the knee.	No	Obsolete
35751	Transcutaneous electrical stimulation lead	A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.	No	Active
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