Search Results

HIVOX OTC Electrical Stimulator, EM59-1

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

SH: This function is designed to be used for temporary relief of minor aches and pains.

HIVOX OTC Electrical Stimulator, EM59-2

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

EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

SH: This function is designed to be used for temporary relief of minor aches and pains.

HIVOX OTC Electrical Stimulators, EM59-1 and EM59-2, fall into the electrostimulation device category.

EM59-1 provides two basic functions, TENS and SH; EM59-2 provides three basic functions, TENS, EMS and SH:

(1) Electrical stimulation of nerve tracts (TENS)

(2) Electrical stimulation of muscle tissue (EMS)

(3) Superficial heat (SH)

Both two models feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general wellbeing, pain relief, maintaining physical fitness, relaxation, muscle revitalisation and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.

The size of the self-adhesive electrode gel pad is 45x45 mm supplied by Shaoxing DL Healthcare Co., Ltd. It is an OTC medical device cleared by FDA under K182111. On the other hand, the electrode made by PET, sponge, PCB and protect cases is designed by HIVOX BIOTEK INC.

The provided text describes the 510(k) summary for the HIVOX OTC Electrical Stimulator (EM59-1, EM59-2). This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain information about acceptance criteria and studies demonstrating device performance for an AI/ML powered device, as the device described is an electrical stimulator, not an AI/ML product.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types) because it is not present in the provided document.

Ask a specific question about this device