(119 days)
TENS:
PL-029K29, PL-029K30, and PL-029Q are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PL-029K29, PL-029K30, and PL-029Q are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS:
PL-029K29, PL-029K30, and PL-029Q are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and for strengthening muscles in the arms, abdomen. legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
PL-029K29, PL-029K30, and PL-029Q are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
PL-029K30 and PL-029Q is intended for temporary relief of minor aches and pains.
The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). the device may also provide heat for temporary relief of minor aches and pains.
The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/light if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.
The electrodes cleared include the electrode patches/pads and electrode garments, which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients (such as lidocaine, menthol, and/or cannabidiol) used in the biocompatible electrodes is withheld as the trade secret and may be disclosed as requested.
The provided text is a 510(k) Summary for the StimPlus Patch, a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) with heating function. The document focuses on demonstrating that the subject device is substantially equivalent to legally marketed predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study involving human patients.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment (especially pertaining to clinical performance) cannot be extracted from this document because the submission method relies on demonstrating substantial equivalence to pre-existing, cleared devices rather than a de novo clinical performance study.
However, I can extract the information related to the non-clinical tests and the comparison of the device's technical specifications to those of its predicates, which serve as a form of "acceptance criteria" for demonstrating substantial equivalence.
Here's the breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to predicate devices. This is achieved by showing that the subject device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety or effectiveness. The core of this is the comparison table of technical parameters.
Table: Comparison of Subject Device (StimPlus Patch) to Predicate Devices
| Parameter | Subject Device (K200561) Performance | Primary Predicate (K162517) Performance | Secondary Predicate (K141260) Performance | Equivalence Claim |
|---|---|---|---|---|
| Intended Use | TENS: Temporary relief of pain, chronic pain, arthritis pain. PMS: Improve muscle performance, tone, strength; temporarily increase local blood circulation. Heating: Temporary relief of minor aches and pains. | TENS: Temporary relief of pain, chronic pain, arthritis pain. PMS: Improve muscle performance, tone, strength; temporarily increase local blood circulation. Heating: Temporary relief of minor aches and pains. | Temporary relief of pain associated with sore and aching muscles. | Identical |
| Prescription or OTC | OTC | OTC | OTC | Identical |
| Power Source(s) | Rechargeable or non-rechargeable battery | Rechargeable battery | Non-rechargeable battery | Identical |
| Method of Line Current Isolation | Battery Supply | Battery Supply | Battery Supply | Identical |
| Patient Leakage Current: Normal Condition (μA) | 2.0 | 2.0 | 2.0 | Identical |
| Patient Leakage Current: Single Fault Condition (μA) |
§ 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).