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K Number
K233492
Device Name
EMS Neck Massager
Manufacturer
Xiamen Comfier Technology Co., Ltd
Date Cleared
2023-12-20

(51 days)

Product Code
NGX
Regulation Number
890.5850
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EMS Neck Massager is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

Not Found

AI/ML Overview

I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria.

The provided text is an FDA 510(k) clearance letter for an "EMS Neck Massager." This type of letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It lists the regulation, product code, and indications for use.

However, it does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample size, data provenance, expert qualifications, or adjudication methods for a test set.
  • Information about multi-reader multi-case studies or effect sizes.
  • Results from standalone algorithm performance.
  • Details about the type of ground truth used or the training set size/ground truth establishment.

This document is a regulatory communication, not a performance study report.

§ 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).