(146 days)
Transcutaneous Electrical Nerve Stimulation (Program 2, 3, 4, 6, 8, 9): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Powered Muscle Stimulation (Program 1, 5, 7, 10, 11, 12): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
MHD TENS is portable and DC 3.7V battery powered device, offering both transcutaneous electrical nerve stimulator (TENS) and powered muscle stimulator (PMS) qualities in one device. MHD TENS has 12 operation programs, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electronic stimulatory module has the operating elements of Switch, LCD Display screen, Screen lock key, Intensity Modification keys, Timing key, Output sockets, and USB port for battery charging. The LCD screen can display treatment remaining time, battery power, selected program, output port, current intensity, selected intensity and lock state. The device is equipped with accessories of electrode pads, electrode cables, a screen stylus, a battery charger and a USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the AC charger and the built-in lithium battery. The screen stylus is used to touch and operate the display screen. All accessories, including the USB cable, electrode pads, electrode cables, and the charger can only be replaced by the electrodes are interchangeable. The application area of electrode pads must be larger than 12cm². The electrode pads are provided by Shenzhen Mailuokang Technology Co., Ltd. with 510(k) cleared Number K152815.
This FDA 510(k) summary describes the MHD TENS device and establishes its substantial equivalence to a predicate device (K143268). The provided document does not contain information about a study proving the device meets acceptance criteria in the manner typically expected for AI/ML device performance (e.g., clinical study with human readers, ground truth establishment, etc.). This is because the MHD TENS is a physical electrical stimulation device, not an AI/ML diagnostic or therapeutic system.
Instead, the "acceptance criteria" for a device like the MHD TENS are compliance with recognized electrical safety and performance standards, and comparison with a legally marketed predicate device to demonstrate substantial equivalence. The "study" proving it meets these "acceptance criteria" consists of engineering tests and comparisons to the predicate.
Here's the information extracted and formatted, noting where AI/ML-specific criteria are not applicable:
Acceptance Criteria and Device Performance for MHD TENS
Device Name: MHD TENS
510(k) Number: K190115
Predicate Device: K143268
1. Table of Acceptance Criteria (as indicated by comparison to predicate and safety standards) and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Comparison & Standards) | Reported Device Performance (MHD TENS) | Note from document regarding comparison to predicate |
|---|---|---|
| Intended Use: | ||
| - Temporary pain relief for sore/aching muscles | To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | Same |
| - Stimulate healthy muscles to improve performance | It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | Same |
| Electrical Safety & Performance (via Standards): | ||
| Patient Leakage Current (Normal Condition) |
§ 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).