MyOnyx

Basic Information

• Brand Name: MyOnyx
• Primary DI: 07540191000555
• Version / Model: SA9000
• Company Name: Technologie de Pensée Ltée
• Labeler DUNS: 209284132
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-16
• Public Version: 4
• Public Version Date: 2023-07-25
• Public Version Status: Update
• Public Device Record Key: c5d11850-9499-4f01-8562-3dcf102e078b

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
HCC	Device, Biofeedback	Neurology	882.5050	2
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	876.5320	2
IPF	Stimulator, Muscle, Powered	Physical Medicine	890.5850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63697	Psychophysiological biofeedback system	A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.	No	Active
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	No	Active
65014	Perineal orifice incontinence-control electrical stimulation system, professional	An assembly of devices intended exclusively for professional use in a healthcare facility designed to treat urinary and/or faecal incontinence through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions; some types also perform electromyography (EMG) measurements. It consists of an electrically-powered external pulse generator/EMG/biofeedback unit with controls/display (e.g., hand-held remote control), software, and a cabled or cordless cylinder-like probe with surface electrodes for insertion into the vagina and/or anus. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540191000555	GS1

Premarket Submissions

Submission Number	Supplement Number
K053434	000