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K Number
K192589
Device Name
Everyway OTC TENS/EMS Combination
Manufacturer
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
Date Cleared
2019-12-19

(90 days)

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

TENS: intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes B/N/M/SD1/SD2 as adjustable mode and P1 to P12 preset programs only for EV-906A).

EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes C/S/A as adjustable mode and P13 to P24 preset programs only for EV-906A).

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device (EV-906 & EV-906A OTC TENS/EMS Combination). This type of document is administrative and confirms that the device is substantially equivalent to a legally marketed predicate device.

It does not contain information about:

  1. Acceptance criteria and reported device performance related to a study. The letter states that the 510(k) submission was not re-reviewed for the administrative correction, and the original letter from Dec 19, 2019, simply states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent." This determination is based on a comparison to a predicate device, not on clinical performance acceptance criteria or a study proving performance against such criteria.
  2. Sample size, data provenance, expert numbers, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth methods. These are details typically found in a clinical study report or a summary of safety and effectiveness, which are not part of a 510(k) clearance letter.

Therefore, I cannot fulfill your request using the provided input. The document confirms the regulatory clearance of a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device as substantially equivalent to a predicate, but it does not detail the specific performance studies, acceptance criteria, or methodology that your questions pertain to.

§ 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).