Neo Sculptor (OF-NEO001)

• K Number: K242186
• Device Name: Neo Sculptor (OF-NEO001)
• Manufacturer: OFAN Intelligent Technology (Guangzhou) Co. Ltd.
• Date Cleared: 2024-09-17 ( 54 days)
• Product Code: NGX
• Regulation Number: 890.5850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The device is indicated to be used for:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.

· Strengthening, Toning and Firming of buttocks and thighs.

·Improvement of muscle tone and firmness, for strengthening muscles in arms.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) clearance letter from the FDA for the medical device "Neo Sculptor (OF-NEO001)". It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts used for a test set.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used, or details about the training set size or how its ground truth was established.

The letter primarily focuses on regulatory clearance, general controls, and compliance requirements rather than specific performance study data or acceptance criteria.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).