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To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot, due to strain from exercise or normal household and work activities

Device Description

The Low-Frequency Therapy Instrument is a product that adopts modern electronic science and technology to produce low-frequency electrical pulse and transmit that through the skin to the underlying peripheral nerves by electrodes, in order to reach the therapeutic aim.

There are three models of Low-Frequency Therapy Instrument which are KTR-201, KTR-202, KTR-203. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, and exquisite; 2) they have different treatment modes which can satisfy various demands, thus can be used by a wider range of people; 3) LCD display with a big screen makes the operation easy and clear, and the contents displayed on LCD can guide the treatment.

The Low-Frequency Therapy Instrument is mainly composed of the host and electrode patches and it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto treatment areas and press power button to turn the power on. The modes and intensity can be selected according to needs. The current status is displayed on LCD.

AI/ML Overview

This FDA 510(k) submission describes the "Low-Frequency Therapy Instrument" (Models: KTR-201, KTR-202, KTR-203), a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, the acceptance is implied by demonstrating substantial equivalence to a predicate device (Shenzhen OSTO Technology Company Limited's Health Expert Electronic Stimulator, Model AST-300C and AST-300D, K133929) and compliance with relevant voluntary standards.

The "Technological characteristics and substantial equivalence" table (pages 5-6) serves as the core comparison for "performance." Key metrics and their comparison to the predicate are:

Parameter	Subject Device (K170205)	Primary Predicate (K133929)	Remark / Implied Acceptance
Indications for Use	Temporary pain relief for sore/aching muscles (shoulder, waist, back, arm, leg, foot) due to strain from exercise/normal activities.	Temporary pain relief for sore/aching muscles (shoulder, waist, back, back of the neck, arm, leg, foot) due to strain from exercise/normal activities by applying current to stimulate nerve.	Similar. The subject device's indications are slightly narrower (omitting "back of the neck"), but fundamentally the same therapeutic area and type of pain relief. Implied acceptance: performs a similar therapeutic function for similar conditions.
Regulation Number	21 CFR 882.5890	21 CFR 882.5890	Identical. Implied acceptance: operates under the same regulatory classification.
Product Code	NUH	NUH, NGX	Similar. NUH is shared, indicating the core function. Implied acceptance: fits the same product category.
Class	Class II	Class II	Identical. Implied acceptance: same regulatory class.
OTC/Rx	OTC	OTC	Identical. Implied acceptance: same intended availability.
Power Supply	KTR-201: DC 3V, 30 mA; KTR-202: DC 4.5V, 100 mA; KTR-203: DC 3V, 30mA	100-240VAC, 50-60Hz, 0.1A	Different. Predicate is mains-powered. Remark states: "Predicate is powered by mains supply but does not affect safety and effectiveness of subject device." Implied acceptance: different power source does not compromise safety/effectiveness.
Output Modes	KTR-201: 10; KTR-202: 10; KTR-203: 5	25	Identical. (This remark seems incorrect; the numbers are different for all subject models compared to the predicate's 25. It should likely state "Similar" or "Different but does not affect...") Implied acceptance: sufficient modes for therapy.
Output Channels	KTR-201: 1; KTR-202: 1; KTR-203: 2	2	Similar. Remark states: "Does not affect safety and effectiveness of subject device." Implied acceptance: sufficient channels for therapy.
Timer Range	15 mins	25 mins	Different. Remark states: "Different but does not affect safety and effectiveness of subject device." Implied acceptance: sufficient timer for therapy sessions.
Waveform	Pulsed symmetric, biphasic, square wave	Pulse symmetric, biphasic, rectangular with interphase interval	Similar. Implied acceptance: provides therapeutically similar electrical stimulation.
Max Output Voltage	44V@500ohm, 58V@2kohm, 63.5V@10kohm	44V±10% @500ohm, 80V±10% @2kohm, 112V±10@10kohm	Similar. Implied acceptance: within acceptable therapeutic range.
Max Output Current	88mA@500ohm, 29mA@2kohm, 6.35mA@10kohm	88mA±10% @500ohm, 40mA±10% @2kohm, 11.2mA±10% @ 10kohm	Similar. Implied acceptance: within acceptable therapeutic range.
Net Charge (per pulse)	0µC @500ohm	0µC @500ohm	Identical. Important for safety to prevent DC component. Implied acceptance: safe.
Max Phase Charge	11.7µC @500ohm	12.78μC@500ohm	Similar. Implied acceptance: therapeutically comparable and safe.
Max Average Current (500ohm)	7.4mA	0.968mA	Different. Remark states: "Although the maximum average current is different, it is

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