# K082377: Tenscare Itouch  Model (S) Easy and Plus

- Pathway: 510(k) (Abbreviated)
- Applicant: Tenscare, Ltd.
- Decided: Feb 9, 2009 after 175 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
Longest line of descent: 2 generations back to K021359 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040253: Easy Med TN-28 C, Easy Med Instrument Co., Ltd. (2004) Summary page 2.
- K032720: Gem-Stim Tens, Models GM3XY and GM3AXY, Gemore Technology Co, Ltd. (2003) Summary page 2.

## Indications for use
TENS stands for Transcutaneous Electrical Nerve Stimulation. This TENS system is indicated for: * Symptomatic relief and management of chronic, intractable pain. * Adjunctive treatment for post-surgical and post-trauma acute pain.

Source page: https://510kreport.com/device/K082377
Methodology: https://510kreport.com/methodology