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510(k) Data Aggregation
(217 days)
EasyStim TN28 OTC is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
EasyStim TN28 OTC is a portable, battery powered T.E.N.S. device for pain relief intended for over-the-counter use.
There are totally eight (8) modes that are intended for application to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot.
The accessories include electrode cable and electrodes pads which are placed on the specific body part. Generally, the electrodes are connected to the device through electrode cable. The device produces either a fixed or modulated electrical signal through electrodes normally placed on a patient's skin over the area of pain.
Since the device is battery powered, there is no connection to AC mains supply.
The provided document is a 510(k) Summary for the EasyStim TN28 OTC device, a Transcutaneous Electrical Nerve Stimulator (T.E.N.S.). It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of diagnostic or treatment performance.
Here's an analysis based on the information provided, addressing the questions as best as possible within the scope of the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or treatment effectiveness, as would be common for AI/ML-based medical devices or novel therapies. Instead, the substantial equivalence hinges on meeting electrical safety, electromagnetic compatibility, usability, risk management standards, and having similar technical characteristics and indications for use as predicate devices.
The "device performance" reported is primarily a comparison of its technical specifications to those of legally marketed predicate devices.
| Attribute | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (EasyStim TN28 OTC) |
|---|---|---|
| Indications for Use | Same as predicate devices | Relief of pain associated with sore or aching muscles of lower back, arms, or legs due to strain from exercise or normal household and work activities. |
| Product Code | NUH (or similar, like GZJ) | NUH |
| Regulation No. | 21 CFR 882.5890 | 21 CFR 882.5890 |
| Prescriptive or OTC | OTC | OTC |
| Environment of use | Clinics, hospital and home environments | Clinics, hospital and home environments |
| Maximum Phase charge (500 ohm) |
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