(14 days)
APPLICABLE FOR TENS 7000 AND TWIN STIM:
This device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief and management of chronic (long term) intractable main and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems
APPLICABLE FOR EMS 7500 and TWIN STIM:
This device is an electrically powered muscle stimulator indicated for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing ouscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy
This series, which includes models TENS 7000, EMS 7500, and TWIN STIM, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The three models have the same housing. The process to set the parameter and attach lead wires to the unit are also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings.
The TENS 7000 is a TENS device with 5 modes and adjustable pulse rate, pulse width and timer. The EMS 7500 is an EMS device with 3 modes and adjustable pulse rate, pulse width, contraction time, relaxation time, ramp time and timer. The TWIN STIM is a combination unit with both TENS and EMS functions. The function can be selected by press buttons. The range of settings are identical to those of TENS 7000 and EMS 7500. The difference on the three units can be identified by the liquid crystal display.
The provided text is a 510(k) summary for TENS and EMS devices (Koalaty Products, Inc., K080661). It describes the devices' intended use and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods.
The 510(k) summary primarily focuses on:
- Device Identification: Trade names (TENS 7000, EMS 7500, TWIN STIM), common names, and classification names.
- Description of the Device: General function as Transcutaneous Electrical Nerve Stimulators (TENS) for pain relief and/or Electrical Muscle Stimulators (EMS) for muscle stimulation, noting adjustable parameters and shared housing.
- Intended Use: Detailed indications for TENS (pain relief, chronic/intractable pain, post-surgical/traumatic pain) and EMS (relaxing muscle spasms, increasing local blood circulation, preventing venous thrombosis, muscle re-education, maintaining/increasing range of motion, preventing disuse atrophy).
- Substantial Equivalence Claim: The devices are claimed to be safe and effective as compared to specific predicate devices (Models EV-804, EV-805, EV-806 from Everyway Medical Instruments Co., Ltd. - K020749, K071951).
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) because it is not present in this 510(k) summary document.
To answer your specific questions, one would need access to the full 510(k) submission, which would typically include detailed testing reports and clinical data (if applicable for the specific device type and regulatory pathway). Based on the provided text, the device's "performance" is implicitly deemed equivalent to the predicate devices, but no explicit performance metrics or studies are detailed.
§ 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).