(272 days)
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9~25)
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.
Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
The provided text is a 510(k) Pre-Market Notification for a medical device, the "Health Expert Electronic Stimulator." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.
Therefore, the document does not contain the type of AI-specific acceptance criteria or detailed study information typically found for novel AI/ML medical devices. The device in question is an electronic stimulator, not an AI/ML-driven diagnostic or therapeutic device.
The "Test Summary" and "Comparison to predicate device" sections outline the types of testing and comparisons performed for this device. These are primarily engineering, electrical, and biocompatibility tests, alongside a comparison of technical specifications to a previously cleared device.
Specifically, the document does not provide information on:
- AI-specific Acceptance Criteria: The device is not an AI/ML product.
- Study Proving Device Meets Acceptance Criteria for AI: No AI-specific studies were conducted because the device is not AI.
- Sample size for test set (for AI): Not applicable.
- Data provenance (for AI): Not applicable.
- Number of experts for ground truth (for AI): Not applicable.
- Qualifications of experts (for AI): Not applicable.
- Adjudication method (for AI): Not applicable.
- MRMC comparative effectiveness study for AI: Not applicable.
- Standalone (algorithm-only) performance for AI: Not applicable.
- Type of ground truth used (for AI): Not applicable.
- Sample size for training set (for AI): Not applicable.
- How ground truth for training set was established (for AI): Not applicable.
The "acceptance criteria" for this device are implicitly derived from the general and special controls for Class II medical devices, and the demonstrated substantial equivalence to the predicate device (K133929). This equivalence is shown through comparison of intended use, technical specifications, and compliance with relevant electrical safety, EMC, biocompatibility, usability, and software verification/validation standards.
Here's what the document does describe in terms of performance and testing:
1. Table of Acceptance Criteria (Implied by Equivalence) and Reported Device Performance:
The "Comparison to predicate device and conclusion" section (Pages 5-6) serves as the primary "performance" and "acceptance" comparison. The acceptance is based on demonstrating that the subject device's characteristics and performance are substantially equivalent to the predicate, and that any differences do not raise new safety or effectiveness issues.
| Elements of Comparison (Implied Acceptance Criteria) | Subject Device Performance | Predicate Device Performance | Remark (Fulfillment of "Acceptance" - SE = Substantially Equivalent) |
|---|---|---|---|
| Intended Use (PMS & TENS) | PMS (Mode 1 | PMS (Mode 1 | SE |
| Power Source(s) | Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A | Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A | SE |
| Method of Line Current Isolation | Type BF Applied Part | Type BF Applied Part | SE |
| Patient Leakage Current | NC (Not specified numerically, implying compliance) | AC: 54.5μA, DC: 0.5μA | SE (implies within acceptable limits vs predicate) |
| SFC (Single Fault Condition) Leakage Current | NC (Not specified numerically, implying compliance) | AC: 120.0μA, DC: 0.6μA | SE (implies within acceptable limits vs predicate) |
| Avg DC current (device on, no pulses) |
§ 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).