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K Number
K232242
Device Name
BEAR 2 Body
Manufacturer
FOREO Inc.
Date Cleared
2024-05-13

(290 days)

Product Code
NFO
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the FOREO Inc. BEAR 2 Body device. This letter indicates that the device has been found substantially equivalent to a predicate device and is intended for over-the-counter cosmetic use.

However, the document does not contain any of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. The FDA clearance letter itself does not typically include such detailed technical study reports.

Therefore, I cannot provide the requested information based on the text provided.

§ 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).