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KTR-2240,KTR-2250,KTR-2610,KTR-2640,KTR-2650:(TENS, EMS, FITNESS)

TENS (Mode~20): 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.

EMS (Mode 2140): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 4150): Improvement of abdominal tone, strengthening of the abdominal muscle development of firmer abdomen.

KTR-2241,KTR-2251,KTR-2242,KTR-2252,KTR-2611,KTR-2641,KTR-2612,KTR-2612,KTR-2652: (TENS)

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.

The Low-frequency Multi-function physiotherapy instrument is a portable and battery powered multifunctional device. The low-frequency multi-function physiotherapy instrument (models: KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650) offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulation. It has 50 operation modes, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. And the TENS (Mode 120) is 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. EMS (Mode 2140) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. FITNESS (Mode 41~50) is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

The low-frequency multi-function physiotherapy instrument (models: KTR-2241, KTR-2242, KTR-2252, KTR-2611, KTR-2641, KTR-2612, KTR-2612, KTR-2652) offering Transcutaneous Electronic Nerve Stimulator (TENS). It has 15 operation mode, and 6 automatic mode, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. The TENS (Mode 1-15) is intended 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.

The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.

The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode.

The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit.

The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

The medical device in question is a "Low-frequency Multi-function physiotherapy instrument" that functions as a Transcutaneous Electrical Nerve Stimulator (TENS), Electrical Muscle Stimulation (EMS), and/or a FITNESS device depending on the model. This is a Class II device.

The provided document describes a 510(k) submission (K200177) where the manufacturer, Shenzhen Kentro Medical Electronics Co., Ltd, aims to demonstrate substantial equivalence to previously cleared predicate devices. The study conducted to prove the device meets acceptance criteria is primarily based on nonclinical (bench) testing and comparison of technical specifications with predicate devices, rather than a clinical trial with human subjects.

Here's the detailed breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely implied by compliance with recognized electrical safety and biocompatibility standards, and by demonstrating similar technical specifications to predicate devices. The "reported device performance" is essentially the subject device's specifications and its compliance with stated standards.

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KTR-2210, KTR-2220, KTR-2230: (TENS, EMS, FITNESS)

TENS (Mode1~20): 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.

EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41-50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen.

KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (TENS)

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.

Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulator (EMS) and FITNESS qualities.

Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) has 50 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body massage.

The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.

The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode.

The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit. All the accessories, including electrode pads, electrode wire, and batteries can only be changed by special person.

The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

The provided text describes a 510(k) premarket notification for a Low-frequency Multi-function physiotherapy instrument. This document primarily focuses on establishing substantial equivalence to predicate devices through a comparison of technical specifications and an assessment of safety and performance testing against recognized standards. It does not detail a study involving specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity) for an AI/CADe device, as the device itself is a physiotherapy instrument, not a diagnostic imaging AI.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, expert qualifications, HRMC studies, standalone performance, ground truth establishment for training, etc.) are not applicable in this context.

However, I can extract the closest equivalents to acceptance criteria and reported "performance" based on the provided safety and performance tests.

Here's a breakdown of the information that can be extracted:

1. A table of acceptance criteria and the reported device performance

For a physiotherapy instrument, "acceptance criteria" relate to meeting safety and performance standards. The "reported device performance" is that the device complies with these standards.

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