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510(k) Data Aggregation
(324 days)
HEALTH EXPERT ELCTRONIC STIMULATOR
PMS (Mode 18)25)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9
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.
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, as well as certain non-electrical rolling massage through one massage roller.
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.
Here's a breakdown of the acceptance criteria and study information for the Health Expert Electronic Stimulator, Model AST-300C and AST-300D, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define "acceptance criteria" as a pass/fail threshold for specific metrics. Instead, it demonstrates substantial equivalence to predicate devices by showing that the subject device's performance aligns with relevant safety and performance standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 62366) and FDA guidance documents.
The table below summarizes the device's technical specifications and compares them to the predicate devices, highlighting where the subject device "complies" with the established standards and guidance, which effectively serves as its acceptance criteria. "SE" in the remarks column generally means "Substantially Equivalent," implying the feature meets the necessary criteria for equivalence.
| Elements of Comparison | Acceptance Criteria (Predicate / Standard Adherence) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use & Indications for Use | Matches predicate devices for PMS and TENS. | PMS (Mode 1 |
| Power Source(s) | Complies with IEC 60601-1 requirements. | Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A |
| Method of Line Current Isolation | Type BF Applied Part. | Type BF Applied Part |
| Patient Leakage Current | Complies with IEC 60601-1 requirements (predicate value: 2.0µA). | NC AC: 54.5µA, DC: 0.5µA; SFC AC: 120.0µA, DC: 0.6µA |
| Average current through electrodes when device is on but no pulses are being applied | Complies with IEC 60601-1 requirements (predicate value: |
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