LogoFDA 510(k) Search
K Number
K171026
Device Name
Mytens Model: BW-TSX
Manufacturer
Bewell Connect Corp.
Date Cleared
2017-11-01

(210 days)

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

TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

Mytens Model: BW-TSX

AI/ML Overview

The provided text describes an FDA 510(k) clearance letter for a device named "Mytens Model: BW-TSX". This letter confirms substantial equivalence to predicate devices and outlines the indications for use, but it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the input text. The 510(k) clearance letter is a regulatory document affirming equivalence, not a detailed study report.

§ 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).