(249 days)
TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Mode 1,3,4,5,6
PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Mode 2,6
The subject device MSLS60F is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), intended for the over-the-counter use to temporarily relieve pain and stimulate muscle in different body areas. This double-channel subject device, which is compact, portable, effectively transfer programmed electrical pulses directly through the self-adhesive electrodes to the suggested area of the body where the electrodes are placed. It delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief and muscle stimulation. The subject device has 6 operation modes which can give certain electrical pulse through the 4 pcs of electrodes placed on the skin to help users to enjoy body stimulation. The subject device 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 the pulse, and time remaining of an application mode. The subject device could be easily operated through its toggle switch or buttons to manually realize its functions according to the need of users. The subject device is equipped with accessories of the electrodes, lead wires, AC adapter and USB cable. The lead wire is used to connect the electrodes to the main unit; the USB cable is used to connect the AC adapter to the main unit when charging the built-in Li battery; the pads holders are used to storage the electrodes after therapy treatment for the convenience. The self-adhesive electrodes are important accessories of the subject device, and are contact with the skin surface. It is consists of gel, carbon film, cloth backing ,and electrode connector. The electrode is complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
The document describes the acceptance criteria and study for the MSLS6QF TENS/PMS Device, establishing its substantial equivalence to a predicate device (IQ Technologies, K131290).
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to a legally marketed predicate device (IQ Technologies, K131290). This is achieved by comparing technical characteristics, specifications, and intended use, and complying with relevant voluntary standards.
| Acceptance Criteria Category | Specific Criteria/Comparison Point | Subject Device (MSLS6QF) Reported Performance | Predicate Device (IQ Technologies) Reported Performance | Judgment/Comment |
|---|---|---|---|---|
| Intended Use | TENS for pain relief | Temporary relief of pain in shoulder, waist, back, upper/lower extremities from strain. Modes 1,3,4,5,6. | Temporary relief of pain in shoulder, waist, back, upper/lower extremities from strain. | SE |
| PMS for muscle performance | Stimulate healthy muscles to improve/facilitate muscle performance. Modes 2,6. | Stimulate healthy muscles to improve/facilitate muscle performance. | SE | |
| Classification | Use Type | Over-The-Counter (OTC) | Over-The-Counter (OTC) | SE |
| Operational Principle | Mechanism of action | Generate small electrical pulses to activate nerves/muscles. | Generate small electrical pulses to activate nerves/muscles. | SE |
| Electrical Safety | IEC 60601-1 (General req. for basic safety & essential performance) | Compliance demonstrated through non-clinical testing. | Compliance demonstrated. | SE |
| IEC 60601-1-2 (EMC Req. & Tests) | Compliance demonstrated through non-clinical testing. | Compliance demonstrated. | SE | |
| IEC 60601-2-10 (Nerve & Muscle Stimulators) | Compliance demonstrated through non-clinical testing. | Compliance demonstrated. | SE | |
| Patient Leakage Current | Passed ( |
§ 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).