# K961809: She-LI Tens Stimulator Model SL-101 RX

- Pathway: 510(k) (Traditional)
- Applicant: Medi Consultants, Inc.
- Decided: Feb 26, 1997 after 292 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Electreat TENS device: named in the summary without a submission number

## 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.

Source page: https://510kreport.com/device/K961809
Methodology: https://510kreport.com/methodology