# K163611: Pain Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Xinbo Electronic Co., Ltd.
- Decided: Sep 19, 2017 after 271 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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: 6 generations back to K940301 (1994). 27 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133929: Health Expert Elctronic Stimulator, Shenzhen Osto Technology Company Limited (2014) Summary page 4.
- K143207: Revitive IX (OTC), Actegy, Ltd. (2015) Summary page 4.
- K150277: Pain Therapy System, Model PTS-II, Counter Scientific Development (Gz), Ltd. (2016) Summary page 4.

## Most influential descendants
- K230443: TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) (2023), 0 descendants of its own
- K200237: Transcutaneous Electronic Nerve Stimulator (2020), 0 descendants of its own

## Indications for use
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (Choose Mode B or C). To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode A). To temporarily increase local blood circulation in healthy muscles (Choose Mode A).

Source page: https://510kreport.com/device/K163611
Methodology: https://510kreport.com/methodology