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.
| Element of Comparison | Subject Device (Ems Foot Stimulator) | Primary Predicate Device (K203574) | Secondary Predicate Device (K190783) | Remark |
|---|---|---|---|---|
| Intended Use | PMS (stimulate healthy muscles), TENS (temporary pain relief), Heating (temporary minor aches/pains) | TENS (temporary pain relief), EMS (stimulate healthy muscles), SH (temporary minor aches/pains) | PMS (stimulate healthy muscles), TENS (temporary pain relief) | Same |
| Power Source | Adaptor Input: 100-240Vac, Output: DC12V-3A | Rechargeable battery | Adaptor Input: 100-240Vac, Output: 5Vdc, 2A | Similar (Note 1) |
| Function and Design | Electrical stimulation and heat | Electrical stimulation and heat | Electrical stimulation and heat | Same |
| Heating Setting | Adjustable | Low and high | Adjustable | Same |
| Output Patterns | Electrical stimulation only, Heat only, Electrical stimulation + heat simultaneously | Electrical stimulation only, Heat only, Electrical stimulation + heat simultaneously | Not public available | Same |
| Method of Line Current Isolation | Type BF Applied Part | N/A (internal power source) | Type BF Applied Part | Same |
| Patient Leakage Current (NC) | AC: 54.5μA, DC: 0.5μA | 6.0 μΑ | AC: 54.5μA, DC: 0.5μA | Same |
| Patient Leakage Current (SFC) | AC: 120.0μA, DC: 0.6μA | 5.6 μΑ | AC: 120.0μA, DC: 0.6μA | Same |
| Average DC current through electrodes (no pulses) |
§ 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).