TENS & EMS Stimulator (MHD-1083)

• K Number: K241678
• Device Name: TENS & EMS Stimulator (MHD-1083)
• Manufacturer: Shenzhen Minghuangda Electronics Co., Ltd.
• Date Cleared: 2024-09-09 ( 90 days)
• Product Code: NUH , NGX
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K190115 , K133929
• Predicate For: N/A

Intended Use

Transcutaneous Electrical Nerve Stimulation (Program 3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36): 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.

Electrical Muscle Stimulation (Program 1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

TENS & EMS Stimulator(Model:MHD-1083) is portable and DC 3.7V battery powered device, offering both transcutaneous electrical nerve stimulator (TENS) and electrical muscle stimulation (EMS) qualities in one device.
TENS & EMS Stimulator has 36 operation programs, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. And the TENS (Program 3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36) 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.
Electrical Muscle Stimulation (EMS) (Program 1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35) to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
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 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. All accessories, including the USB cable, electrode pads, electrode cables, and the charger can only be replaced by the specialized person. Please ask the retailer to replace it.
The electrodes are interchangeable. The application area of electrode pads must be larger than 10cm². The electrode pads are provided by Dong Guan Ou Kang Electronics CO., LTD. with 510(k) cleared Number K181234.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a TENS & EMS Stimulator (MHD-1083). This document is focused on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing specific acceptance criteria for a novel AI/ML-driven medical device and then proving it meets those criteria through a dedicated performance study.

Therefore, the requested information regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "ground truth establishment" cannot be found within this document.

This document details the following:

• Acceptance Criteria & Device Performance: The document does not describe acceptance criteria in the typical sense for a new AI/ML algorithm's performance. Instead, it compares the new device's specifications to those of its predicate devices to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it falls within similar ranges or uses similar technology to cleared predicates.

  • Table of Acceptance Criteria and Reported Device Performance: Not applicable in the context of an AI/ML algorithm's performance study. The table provided (on pages 6-7) is a comparison of the new device's technical specifications against two predicate devices (K190115 and K133929). It highlights similarities and differences in parameters like power source, output modes, channels, waveform, maximum output voltage/current, pulse width, frequency, and safety compliance. For example:
    • Parameter: Indications for Use
      • New Device: TENS for temporary pain relief; EMS to stimulate healthy muscles for performance.
      • Predicate K190115: TENS for temporary pain relief; PMS (Powered Muscle Stimulation) to stimulate healthy muscles for performance.
      • Predicate K133929: TENS for temporary pain relief; PMS to stimulate healthy muscles for performance.
      • Comparison: Same (in terms of general use).
    • Parameter: Number of Output Modes
      • New Device: 36
      • Predicate K190115: 12
      • Predicate K133929: 25
      • Comparison: Similar (Note 2 states this difference doesn't impact safety/effectiveness).
    • Parameter: Maximum Output Voltage
      • New Device: 82V±20% @ 500Ω; 158V±20% @ 2kΩ; 168V±20% @ 10kΩ
      • Predicate K190115: 78V±15% @ 500Ω; 153V±15% @ 2kΩ; 161V±15% @ 10kΩ
      • Predicate K133929: 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ
      • Comparison: Similar (Note 3 states differences don't exceed safety limits and meet IEC 60601-2-10 requirements).

• Sample sizes for test and training sets: Not applicable. This submission relies on technical specifications and adherence to recognized safety standards rather than a clinical performance study with test/training datasets for an AI algorithm.

• Data provenance: Not applicable. No clinical data or images are involved for AI training/testing.

• Number of experts and qualifications: Not applicable. Ground truth for an AI algorithm is not established here. The comparison is against established predicate device specifications and recognized safety standards.

• Adjudication method: Not applicable.

• MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic or therapeutic device that involves human readers.

• Standalone performance: Not applicable. The device's operation is purely electrical stimulation, not an AI algorithm.

• Type of ground truth: Not applicable. The "ground truth" here is compliance with electrical safety standards (e.g., IEC 60601 series) and demonstrating that the device's functional parameters are within ranges considered safe and effective, similar to already-cleared devices.

• How ground truth for training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for an electrical stimulator, not an AI/ML-driven device. Therefore, the specific criteria and study details relevant to AI/ML device acceptance (as outlined in your prompt) are not present. The "proof" of the device meeting "acceptance criteria" here is its demonstrated adherence to relevant electrical safety standards and substantial equivalence to predicate devices, focusing on hardware and electrical characteristics.

Regulation Number and Section

§ 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).