Search Results

PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS (mode 4-6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

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

Ems Foot Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS), Powered Muscle Stimulator (PMS) and heating qualities.

Ems Foot Stimulator has 6 modes (PMS mode 13, TENS mode 46), which can give certain electrical pulse through 6 pcs of electrode Pad placed on the body to help users to enjoy body stimulation. There are 2 big electrode pads in foot conductive area for feet placed on the main unit to help users to enjoy sole stimulation. And a heating belt can provide heating treatment on waist area.

The main unit has the operating elements of Power on/off switch, ON/OFF Switch, Display screen, 2 Mode Selection keys, 2 Intensity Selection keys and a time setting key.

The LCD display screen can show selected mode, output intensity of body and sole, heating level and time remaining of an application mode.

The remote controller has a ON/OFF Switch to control the EMS/ TENS treatment, a ON/OFF switch to control heating treatment, 2 mode selection keys, 2 intensity selection keys, 2 heating adjust keys and a time setting key.

The heating belt and foot conductive pad can only warm the waist and foot rang 30 to 41 degree C The Heating adjust keys on remote controller can help user to adjust the temperature for warming the waist and foot simultaneously. The heating time is same as the treatment time you selected. The heating and stimulation can be applied simultaneously.

There are 4 models, model HK701, HK701A, and HK701C, all the four models include a main unit and many accessories. The main unit of the four models are the same, the difference is only the accessories included in the package, so the function is a little different.

This document is a 510(k) summary for the Ems Foot Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) device. The purpose of this summary is to demonstrate substantial equivalence to previously cleared devices, not to present a study proving the device meets a specific set of acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and a detailed study proving performance is not directly available in this type of submission.

Based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific acceptance criteria in a quantifiable table for clinical performance (e.g., sensitivity, specificity for a diagnostic device or a specific clinical outcome for a therapeutic device) nor does it report device performance against such criteria. Instead, it demonstrates substantial equivalence to predicate devices through technical comparisons and compliance with recognized standards.

The document lists performance characteristics for the subject device and predicate devices for comparison. These are not acceptance criteria in the sense of a clinical outcome, but rather technical specifications and safety parameters.

Note 1: The power source difference from predicate devices is addressed by compliance with IEC 60601-1, asserting no safety/effectiveness issue.
Note 2: Differences in "number of output modes," "heating temperature," "output intensity level," "timer range," "maximum current density," and "maximum average power density" are addressed by passing safety tests complying with FDA-recognized consensus standards, asserting no adverse impact on safety/effectiveness.

2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical study was performed." (page 6). Therefore, there is no test set or clinical data provenance in the context of a clinical trial for device efficacy. Performance data provided are from non-clinical tests (biocompatibility, electrical safety, EMC, usability, software V&V). These tests were likely conducted on a representative sample of the manufactured device. Specific sample sizes for these engineering tests are not provided in this summary. The data provenance for non-clinical tests is generally from internal testing or certified external labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study was performed and thus no "ground truth" was established based on expert assessment for a clinical test set.

4. Adjudication method for the test set
Not applicable, as no clinical study was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was performed."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a physical medical device (TENS/PMS unit), not an algorithm or AI. Standalone performance as typically described for AI/software devices is not applicable. The performance demonstrated is through non-clinical bench testing and compliance with electrical, safety, and biocompatibility standards.

7. The type of ground truth used
For the non-clinical tests performed:

• Biocompatibility: Ground truth is established by standards like ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), where the "truth" is whether the materials elicit an adverse biological response.
• Electrical safety and EMC: Ground truth is established by compliance with international standards such as IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, and IEC 60601-1-2.
• Usability Testing: Ground truth is established by compliance with standards like IEC 62366-1 and IEC 60601-1-6.
• Software Verification and Validation Testing: Ground truth is established by FDA's guidance for software in medical devices, assuring that the software functions as intended and does not lead to minor injury.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device that requires a training set and ground truth for training.

Ask a specific question about this device