# K182203: JKH Stimulator Plus

- Pathway: 510(k) (Traditional)
- Applicant: Jkh USA, LLC
- Decided: Mar 14, 2019 after 211 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: 7 generations back to K881114 (1988). 49 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162517: Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13, Jkh Health Co., Ltd. (2017) Summary page 6.
- K031017: Sys*Stim 208 and 208A, Mettler Electronics Corp. (2003) Summary page 6.
- K140333: Ascend, Neurometrix, Inc. (2014) Summary page 6.
- K153704: Strive, Djo, LLC (2016) Summary page 6.

## Most influential descendants
- K191151: JKH Stimulator Plus (2019), 4 descendants of its own
- K231569: ManaFlexx 2 (model: MF002-RX, MF002-OTC) (2023), 1 descendant of its own
- K202159: actiTENS (2020), 1 descendant of its own
- K252767: actiTENS mini (2026), 0 descendants of its own
- K243613: Patch-TEA (Model TRI-21) (2025), 0 descendants of its own

## Indications for use
TENS (Modes 1, 2, 4, 5, 6, 8): PL-029K12 and PL-029K13 are 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. PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes. PMS (also called EMS, Modes 1, 3, 7): PL-029K12 and PL-029K13 are used 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. PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. Heating: The device of PL-029K13 is intended for temporary relief of minor aches and pains. PL-029K12 and PL-029K13 are intended for the following use: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis - Temporary relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Muscle re-education - Maintaining or increasing range of motion - Increase of local blood flow in the treatment area - Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

Source page: https://510kreport.com/device/K182203
Methodology: https://510kreport.com/methodology