Search Results

The She-Li TENS (TM) device is indicated for reducing the symptoms of : Chronic Intractable Pain, and Post Traumatic Acute Pain by placing contacts on the body per instructions by Dr. C.N.Shealy,M.D.,Ph.D. for the type of pain encountered.

The She-Li TENS(TM) utilizes the same solenoid coil and interrupter assembly which is at the heart of the Electreat device. Shrouded receptacles are utilized in the She-Li TENS(TM), as recommended by the Agency. Two Alkaline "C" cell batteries are used in a more up to date mechanical package. The Electrical output of the She-Li TENS (TM) is identical to that of the former Electreat. However, the She-Li TENS(TM) provides safer, shrouded output receptacles for the single channel (just as in the original Electreat device) .

The provided text is a 510(k) summary for the She-Li TENS (TM) Model No. 101-Rx, demonstrating its substantial equivalence to a grandfathered device, the Electreat TENS device. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary focuses on:

• Substantial Equivalence: Establishing that the She-Li TENS (TM) is substantially equivalent to a legally marketed predicate device (the Electreat TENS).
• Device Description: Details on shared components (solenoid coil, interrupter assembly) and improvements (shrouded receptacles, battery type, mechanical package).
• Intended Use/Indications for Use: Reducing symptoms of chronic intractable pain and post-traumatic acute pain.

Therefore, I cannot provide the requested information. The document explicitly states it's a "summary" to meet 21 C.F.R. 807.92, which primarily focuses on substantial equivalence rather than detailed performance study results or acceptance criteria.

To elaborate on why each point cannot be answered:

1. Table of acceptance criteria and the reported device performance: Not present. The document only states the electrical output is "identical" to the predicate, but no specific performance metrics or acceptance criteria are provided.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or related study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable. No test set or adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device (TENS) and not an algorithm.
7. The type of ground truth used: Not applicable. No ground truth is described.
8. The sample size for the training set: Not applicable. No training set is mentioned as this device is not an AI/ML product.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment is described.

Ask a specific question about this device