(433 days)
PMS (Mode 1)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 2)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Physiotherapy instrument has 2 operation modes and one channel, after insert the electrode wire of the electrode pads, just put the electrode pads on the same side of your body, for shoulder, waist, back, back of the neck, arm, leg or foot (depends on your need, please consult your doctor before using if need), which can give certain electrical pulse through 2 pieces of electrode pads on the skin.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity enhancement/weakening keys, language switch button and time selection keys. The LCD display screen can show selected mode, output intensity of body and/or sole, time remaining of an application mode, language display systemy.
The device is equipped with accessories of electrode pads, electrode wire, adapter.
The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
The provided document is a 510(k) summary for a Low-frequency Multi-function physiotherapy instrument. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a new AI/ML-driven medical device.
Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, and ground truth establishment for the training set) is not present in this document.
This document describes a traditional medical device (Physiotherapy instrument) and its submission for FDA clearance via a 510(k) pathway. The test summary mentions "lab bench testing" for electrical safety, electromagnetic compatibility, biocompatibility, usability, software verification and validation, and waveform testing, all according to established IEC and ISO standards and FDA guidance documents. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through engineering and bench testing, rather than extensive clinical studies or performance against specific AI/ML-related metrics.
In summary, this document does not contain the information required to answer the prompt, as it pertains to the clearance of a non-AI/ML medical device through predicate equivalence, not a performance study of an AI/ML device against predefined acceptance criteria.
§ 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).