(99 days)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
The device of the model FM-B2403A is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations.
Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the TENS & EMS Device (Model: FM-B2403A):
Please note: This document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device, not a typical clinical trial report for an AI-powered diagnostic/treatment device. Therefore, many of the typical questions regarding AI device performance studies (like test set provenance, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or explicitly stated in this type of submission. The "acceptance criteria" here refer to regulatory standards and comparative technical specifications, not predictive performance metrics.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Predicate Device Performance (FM-B2403) | Proposed Device Performance (FM-B2403A) | Meets Criteria? |
|---|---|---|---|---|
| Regulatory Information | Regulation Numbers: 882.5890, 890.5850 | 882.5890, 890.5850 | 882.5890, 890.5850 | Yes (SE) |
| Classification: Class II | Class II | Class II | Yes (SE) | |
| Product Code: NUH, NGX | NUH, NGX | NUH, NGX | Yes (SE) | |
| Panel: Physical Medicine; Neurology | Physical Medicine; Neurology | Physical Medicine; Neurology | Yes (SE) | |
| OTC/RX: OTC | OTC | OTC | Yes (SE) | |
| Intended Use | TENS: Temporary relief of pain associated with sore and aching muscles (specified body parts) | Same | Same | Yes (SE) |
| EMS: Stimulate healthy muscles to improve/facilitate muscle performance | Same | Same | Yes (SE) | |
| Physical Characteristics & Safety | Apply parts of the body | Shoulder, waist, back, neck, upper/lower extremities, abdomen, bottom | Shoulder, waist, back, neck, upper/lower extremities, abdomen, bottom | Yes (SE) |
| Power Source | Built-in 3.7V lithium battery | Built-in 3.7V lithium battery | Yes (SE) | |
| Method of Line Current Isolation | BF | BF | Yes (SE) | |
| 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).