(428 days)
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.
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| Electrical Safety: IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 | Complies with standards |
| Electromagnetic Compatibility: IEC 60601-1-2 | Complies with standard |
| Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10 | Complies with standards (for all user-contacting materials) |
| Usability: IEC 62366-1 | Complies with standard |
| Software Verification & Validation: FDA Guidance for Pre-Market Submissions and for Software Contained in Medical Devices | Complies with FDA guidance |
| Waveform Test (Output Specifications): Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning | Complies with guidance; verifies output specifications |
| Patient Leakage Current: (e.g., |
§ 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).