(204 days)
TENS(1,3,4,5,6,21): 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(2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9126
TENS(3,4,5,6,11,12,16): 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(1,2,7,8,9,10,13,14,15): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9186
TENS(3,4,7,8,11): 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(1,2,5,6,9,10,12): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9196
TENS(1015): 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.9): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
PMS(1
TENS & PMS is a portable and DC 3.7V battery powered multifunction device with multiple models, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. The device is equipped with accessories of electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.
The provided text describes a 510(k) premarket notification for a TENS & PMS device. This submission aims to demonstrate substantial equivalence to an already legally marketed predicate device (K121719). The document focuses on comparing the technical characteristics and performance of the new device models (SM9079, SM9126, SM9186, SM9196) against the predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the safety and performance parameters of the legally marketed predicate device (K121719) and compliance with various recognized standards. The reported device performance is demonstrated through the comparative tables (Table 1, 2, 3, 4) where the new device's parameters are listed alongside the predicate device's, and through the statement of compliance with specific IEC and ANSI/AAMI standards.
Since the tables in the document are already in a comparative format, I will summarize the key parameters and their reported performance for one of the new models (SM9079) against the predicate. The "Remark" column in the original tables already serves as a concise statement of whether the new device meets or is similar to the predicate.
Table: Acceptance Criteria and Reported Device Performance (Example: Model SM9079 vs. Predicate K121719)
| Parameter / Acceptance Criteria (Derived from Predicate) | Reported Device Performance (New Device SM9079) | Meets Criteria? | Notes |
|---|---|---|---|
| General Characteristics | |||
| Manufacturer | Hong Qiangxing (Shenzhen) Electronics Limited | Yes | Same |
| Intended Use (TENS) | Temporary relief of pain for specific body parts due to strain | Yes | Same (Expanded list of programs, but comparable) |
| Intended Use (PMS) | Stimulate healthy muscles to improve performance | Yes | Same (Expanded list of programs, but comparable) |
| Type of Use | OTC | Yes | Same |
| Power Source | DC 3.7V lithium battery | Yes | Same |
| Method of Line Current Isolation | Type BF | Yes | Same |
| Patient Leakage Current (Normal Condition) |
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).