Ultra OTC Facial Toning System

• K Number: K183189
• Device Name: Ultra OTC Facial Toning System
• Manufacturer: Micro Current Technology, Inc.
• Date Cleared: 2019-04-17 ( 149 days)
• Product Code: NFO
• Regulation Number: 882.5890
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the text provided, I cannot fulfill your request. The document you provided is an FDA medical device clearance letter for a "Ultra OTC Facial Toning System," which is classified as a "Transcutaneous Electrical Nerve Stimulator For Pain Relief."

This document only covers the regulatory clearance of a physical medical device. It does not contain any information about:

1. Acceptance criteria for an AI/software device.
2. A study that proves a device meets acceptance criteria related to AI/software performance.
3. Specifics of test sets, training sets, ground truth establishment, or expert involvement in relation to AI/software performance.

Therefore, I cannot extract the information needed to populate the table or answer the questions about the study design, as this information is not present in the provided text.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).