(213 days)
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The Healy device is a single channel wearable electrotherapy device that is designed to alleviate temporary and chronic muscle and joint pain on multiple body locations. It delivers microcurrent therapy through the simple and convenient use of the dedicated iOS or Android App, or on product controls. Reusable, selfadhesive and contouring electrodes allow for discreet and convenient placement on multiple pain locations on the body. The system contains one unit, which is rechargeable and is attached to the electrode via cables. The electrode can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Healy system is completed through the available App or on product controls.
The provided text is a 510(k) summary for the Healy device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Omron Avail, Model PM601, K172079) rather than providing detailed acceptance criteria and a study proving the device meets those criteria.
However, based on the information provided, we can infer some details related to acceptance criteria and the underlying studies.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a specific table of acceptance criteria with corresponding performance metrics like a typical clinical trial report. Instead, it relies on demonstrating equivalence to a predicate device by comparing various technological characteristics and performance parameters. The "acceptance criteria" can be interpreted as demonstrating that the device's characteristics are either "No Difference", "Similar", or if different, that the differences "do not raise new questions of safety or effectiveness" when compared to the predicate device.
Here's an aggregated summary table based on the "Substantial Equivalence Comparison Table" and "Output Comparison" in the provided text. The "Acceptance Criteria" column reflects the implicit criteria used for substantial equivalence, i.e., that the device characteristics should be comparable to the predicate. The "Reported Device Performance" is the value for the Healy device. The "Outcome/Compliance" indicates whether the Healy device was found to be acceptable in comparison to the predicate.
| Characteristic | Acceptance Criteria (based on predicate) | Reported Device Performance (Healy) | Outcome/Compliance |
|---|---|---|---|
| General Characteristics | |||
| Regulation | 21 CFR§882.5890 | 21 CFR§882.5890 | No Difference |
| Usage | Over the Counter | Over the Counter | No Difference |
| Intended Use | Relief of pain associated with sore/aching muscles (back, arms, legs, shoulders, feet) from strain; symptomatic relief/management of chronic, intractable pain; relief of pain associated with arthritis. | Same as predicate | No Difference |
| Environment of Use | Clinics, hospital and home environments. | Clinics, hospital and home environments. | No Difference |
| Patient Population | All adults 18 years and older. | All adults 18 years and older. | No Difference |
| Contraindications | Cardiac pacemaker, implanted defibrillator, other implanted metallic/electronic device. | Same as predicate | No Difference |
| Sterility | External contacting device, nonsterile | External contacting device, nonsterile | No Difference |
| Power Source | Rechargeable Lithium Ion Battery | Rechargeable Lithium Ion Battery | No Difference |
| Method of Line Current Isolation | N/A (internal power source) | N/A (internal power source) | No Difference |
| Automatic No Load contact Trip | Yes | Yes | No Difference |
| Automatic Shut Off | Yes | Yes | No Difference |
| Compliance With Voluntary Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 | No Difference |
| Performance Characteristics (Microcurrent mode) | |||
| Waveform | Biphasic | Biphasic | No Difference |
| Shape | Rectangular | Rectangular | No Difference |
| Max Output Voltage (V) @ 500 Ohms | 0.025 (predicate) | 0.030 | Similar (slightly higher, but deemed acceptable for equivalence) |
| Max Output Voltage (V) @ 2k Ohms | 0.100 | 0.100 | No Difference |
| Max Output Voltage (V) @ 10k Ohms | 0.500 | 0.500 | No Difference |
| Maximum Output Current (mA) @ 500 Ohm | 0.050 | 0.050 | No Difference |
| Maximum Output Current (mA) @ 2kOhm | 0.050 | 0.050 | No Difference |
| Maximum Output Current (mA) @ 10kOhm | 0.050 | 0.050 | No Difference |
| Pulse Duration, Sec | 2.50 | 2.50 | No Difference |
| Frequency, Hz | 0.20 | 0.20 | No Difference |
| Maximum Phase Charge (uC) @ 500 Ohms | 125.0 | 125.0 | No Difference |
| Maximum Average Current, mA | 0.025 | 0.025 | No Difference |
| Maximum Current Density, mA/cm² @ 500 Ohms | 0.0008 (predicate) | 0.0010 | Similar (slightly higher, within IEC limit of 2mA/cm², deemed acceptable for equivalence) |
| Maximum Average Power [mW/cm²] @ 500Ohm | 0.00001398 (predicate) | 0.00002500 | Similar (slightly higher, deemed acceptable for equivalence) |
| Regulated Current or Voltage? | Current | Current (and Voltage) | Similar (Healy provides both current and voltage, enhancing safety, deemed acceptable) |
| Patient Leakage Current -normal Condition, uA |
§ 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).