# K162517: Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13

- Pathway: 510(k) (Traditional)
- Applicant: Jkh Health Co., Ltd.
- Decided: Apr 14, 2017 after 217 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: 5 generations back to K912178 (1991). 14 ancestors in all.
25 later devices descend from it; 7 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153520: Electronic Pulse Stimulator, Jkh Health Co., Ltd. (2016) Summary page 4.
- K070299: Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101), Ezfit Technology, Inc. (2007) Summary page 4.

## Most influential descendants
- K182203: JKH Stimulator Plus (2019), 7 descendants of its own
- K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (2021), 4 descendants of its own
- K191151: JKH Stimulator Plus (2019), 4 descendants of its own
- K211403: HIVOX OTC Electrical Stimulator, FT610-B (2021), 3 descendants of its own
- K200561: StimPlus Patch, StimPlus Patch, StimPlus Patch (2020), 2 descendants of its own

## Indications for use
TENS (Modes 1, 2, 4, 5, 6, 8) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS (also called EMS, Modes 1, 3, 7) To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. Heating Mode Temporary relief of minor aches and pains.

Source page: https://510kreport.com/device/K162517
Methodology: https://510kreport.com/methodology