K Number
K961809
Device Name
SHE-LI TENS STIMULATOR MODEL SL-101 RX
Date Cleared
1997-02-26

(292 days)

Product Code
Regulation Number
882.5890
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
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) .
More Information

Not Found

Not Found

No
The description focuses on the electrical and mechanical components, explicitly stating the output is identical to a predicate device from the past, with no mention of AI or ML.

Yes
The device is indicated for reducing symptoms of chronic intractable pain and post traumatic acute pain, which are therapeutic claims.

No

Explanation: The device is indicated for reducing symptoms of pain, which is a therapeutic function, not a diagnostic one. It does not mention identifying or characterizing a disease or condition.

No

The device description explicitly mentions hardware components such as a solenoid coil, interrupter assembly, shrouded receptacles, and batteries, indicating it is a physical device, not software-only.

Based on the provided information, the She-Li TENS (TM) device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for reducing pain symptoms by placing contacts on the body. This indicates a direct interaction with the patient's body for therapeutic purposes.
  • Device Description: The description details an electrical stimulation device that applies current to the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition.

IVD devices are designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. The She-Li TENS (TM) device is clearly a therapeutic device that interacts directly with the patient's body.

N/A

Intended Use / Indications for Use

The She-Li TENS (TM) device is indicated for reducing the symptoms of :

Chronic Intractable Pain, and A.

B. 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. Suitable instructions are included in the Professional Instruction Manual.

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

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) .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

on the body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

K961809

FEB 2 6 1997

APPENDIX "E" 510 (k) Summary

the following 21 C.F.R.807.92, accordance with In information constitutes MEDI Consultants, Inc. summary for the She-Li TENS (TM) Model No. 101-Rx:

MEDI Consultants, Inc. has demonstrated that its TENS (TM) Model No. 101-Rx is substantially She-Li equivalent to the Electreat TENS device, manufactured by the Electreat Inc. of Minneapolis, Minnesota. Since the Electreat was manufactured since prior to 1920, it was 1976 and produced grandfathered as May -28, of continuously till the summer of 1993.

The She-Li TENS(TM) utilizes the same solenoid coil and interrupter assembly which is at the heart of the Shrouded receptacles are utilized in Electreat device. 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. the She-Li TENS(TM) provides safer, shrouded However, output receptacles for the single channel (just as in the original Electreat device) .

The She-Li TENS (TM) device is indicated for reducing the symptoms of :

Chronic Intractable Pain, and A.

B. 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. Suitable instructions are included in the Professional Instruction Manual.

Submitter: MEDI Consultants, Inc.

265 Vreeland Avenue Address : Paterson, New Jersey 07504

Mr. Saul Liss, Ph.D., President Contact Person:

Telephone No: (201) 278-0200

11

Date: May 9, 1996