(333 days)
Model SM9187:
TENS (Mode 1, 3, 4, 5, 6):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model SM9180L & SM9180S:
TENS (Mode 1. 3. 4. 5. 6):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities.
PMS (Mode 1, 2, 3, 4, 5, 6):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Sunmas TENS & PMS (Model SM9187, SM9180L & SM9180S) is a portable battery powered device with a wireless feature for over-the-counter use, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. Sunmas TENS & PMS has totally 6 modes, applying electrical current to electrodes on a patient's skin to relieve pain or build up muscle. Due to different electrode shapes and sizes, Model SM9187 can be used on the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (legs), while Model SM9180L and SM9180S can be used on the shoulder, back and abdomen. Model SM9187 is designed to be controlled by a mobile phone application program (APP) named “Dr.Stim”, through Bluetooth 4.0 technology (Frequency: 2402.0 - 2480.0MHz). The APP is developed by Hong Qiangxing (Shenzhen) electronics Limited. SM9187 consists of a round main unit, two sets of self-adhesive electrode pad, a mobile application (APP), an AC charger and a USB cable. Model SM9180L and SM9180S both have a butterfly-shaped main unit (Frequency: 2450MHz) and can be remotely controlled through wireless technology. SM9180L has a black remote control with an electronic display screen which is powered by two AAA alkaline batteries, while Model SM9180S has a white remote control powered by a CR2032 coin battery. The radio frequency of remote control (both black and white) is 2405.0 - 2470.0MHz. Model SM9180L and SM9180S consists of a unit, two pairs of electrode gels, a remote control (black or white), an AC charger and a USB cable.
This document is a 510(k) Pre-Market Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) device. The purpose of this notification is to demonstrate that the new device, Sunmas TENS & PMS (Models SM9187, SM9180L, SM9180S), is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies, as requested:
1. A table of acceptance criteria and the reported device performance
The provided document doesn't explicitly present a table of "acceptance criteria" in the sense of predefined performance thresholds for a clinical study. Instead, it compares the technical specifications and safety standards compliance of the new device with those of its predicate devices to demonstrate substantial equivalence. The implicit "acceptance criteria" are that the new device's specifications and safety performance are comparable to or meet the standards of the predicate devices.
Below is a table summarizing key comparative performance metrics, drawn directly from the "Substantial Equivalence to Predicate device" tables (Table 1 and Table 2) within the document. The "Reported Device Performance" for the new device is its own specifications, and the "Acceptance Criteria" are implied by the predicate device's specifications and the statement that the new device is "safe and effective as the predicate devices cited above."
| Parameter | New Device (SM9187) Reported Performance | Predicate Device 1 (K121719) Implied Acceptance Criteria | Predicate Device 2 (K143430) Implied Acceptance Criteria |
|---|---|---|---|
| Number of Output Modes | 6 | 6 | 7 |
| Number of Output channels | 1 | 2 | 1 |
| Waveform | Biphasic rectangular, Monophasic rectangular | Biphasic rectangular, Monophasic rectangular | Biphasic rectangular, Monophasic rectangular |
| Patient Leakage Current (Normal Condition) |
§ 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).