# K220578: Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

- Pathway: 510(k) (Traditional)
- Applicant: Bozhou Rongjian Medical Appliance Co., Ltd.
- Decided: May 25, 2022 after 86 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: 5 generations back to K010782 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202893: Transcutaneous Electrical Nerve Stimulator, Wuxi Jiajian Medical Instrument Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K222879: Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (2023), 0 descendants of its own

## Indications for use
The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) 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 of chronic intractable pain and adjunctive treatment in the management of post surgical and post traumatic pain.

Source page: https://510kreport.com/device/K220578
Methodology: https://510kreport.com/methodology