# K020749: Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens

- Pathway: 510(k) (Abbreviated)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Oct 31, 2002 after 238 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: 1 generation back to K010782 (2001). 1 ancestor in all.
15 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010782: Transamerican Tens, Transamerica Medical Systems (2001) Summary page 2.

## Most influential descendants
- K071951: Comfy Series: EV-804, EV-805 & EV-806 (2007), 14 descendants of its own
- K082514: Tens/Ems Combo, Ems, Tens (2008), 6 descendants of its own
- K100117: LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator (2010), 4 descendants of its own
- K112288: Jiajian Tens (2012), 3 descendants of its own
- K102014: Tens Stimulator, Models 2800 and 3000 (2010), 3 descendants of its own

## Indications for use
EV-803 Digital TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient’s skin to treat pain. In particular, this device is indicated for use for: - Symptomatic relief and management of chronic (long term) intractable pain - Adjunctive treatment in the management of post surgical and post traumatic acute pain problems.

Source page: https://510kreport.com/device/K020749
Methodology: https://510kreport.com/methodology