# K191151: JKH Stimulator Plus

- Pathway: 510(k) (Special)
- Applicant: Jkh USA, LLC
- Decided: Jun 21, 2019 after 51 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: 8 generations back to K881114 (1988). 50 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182203: JKH Stimulator Plus, Jkh USA, LLC (2019) Summary page 5.

## Most influential descendants
- K231569: ManaFlexx 2 (model: MF002-RX, MF002-OTC) (2023), 1 descendant of its own
- K243613: Patch-TEA (Model TRI-21) (2025), 0 descendants of its own
- K241119: Transcutaneous Electrical Nerve Stimulator (K6106) (2024), 0 descendants of its own
- K212989: Low-frequency Stimulator (Model: AST-645, AST-646) (2021), 0 descendants of its own

## Indications for use
Over-The-Counter Use: TENS: PL-029K5BL, PL-029K 15, and PL-029T 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-029K5BL, PL-029K 15, and PL-029T are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. The device of PL-029K5BL and PL-029K 15 may be used during sleep. The device of PL-029K5BL and PL-029K15 is labeled for use only with its own compatible electrodes. PMS: PL-029K5BL, PL-029K 15, and PL-029T 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-029K5BL, PL-029K 15, and PL-029T are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. Heating: The device of PL-029T is intended for temporary relief of minor aches and pains. Prescription Use: TENS: PL-029K5BL, PL-029K 15, and PL-029T 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 PMS: PL-029K5BL, PL-029K 15, and PL-029T are intended for the following use: - 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/K191151
Methodology: https://510kreport.com/methodology