K961809 · Medi Consultants, Inc. · GZJ · Feb 26, 1997 · Neurology
Device Facts
Record ID
K961809
Device Name
SHE-LI TENS STIMULATOR MODEL SL-101 RX
Applicant
Medi Consultants, Inc.
Product Code
GZJ · Neurology
Decision Date
Feb 26, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 882.5890
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The She-Li TENS (TM) device is indicated for reducing the symptoms of: A. Chronic Intractable Pain, and 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.
Device Story
Transcutaneous Electrical Nerve Stimulation (TENS) device; utilizes solenoid coil and interrupter assembly; powered by two alkaline C-cell batteries; single-channel output; features shrouded receptacles for safety; operated by patient or clinician per instructions; provides electrical stimulation to reduce pain symptoms.
Clinical Evidence
No clinical data provided; substantial equivalence based on technological similarity to predicate device.
Technological Characteristics
Solenoid coil and interrupter assembly; two alkaline C-cell batteries; single-channel output; shrouded receptacles; mechanical package.
Indications for Use
Indicated for patients suffering from chronic intractable pain or post-traumatic acute pain.
Regulatory Classification
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.
Predicate Devices
Electreat TENS device
Submission Summary (Full Text)
{0}
K961809
FEB 26 1997
APPENDIX "E"
510 (k) Summary
In accordance with 21 C.F.R.807.92, the following information constitutes MEDI Consultants, Inc. summary for the She-Li TENS (TM) Model No. 101-Rx:
MEDI Consultants, Inc. has demonstrated that its She-Li TENS (TM) Model No. 101-Rx is substantially 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 grandfathered as of May 28, 1976 and produced 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 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 She-Li TENS (TM) device is indicated for reducing the symptoms of:
A. Chronic Intractable Pain, and
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.
Address: 265 Vreeland Avenue
Paterson, New Jersey 07504
Contact Person: Mr. Saul Liss, Ph.D., President
Telephone No: (201) 278-0200
Date: May 9, 1996
16
