# K200561: StimPlus Patch, StimPlus Patch, StimPlus Patch

- Pathway: 510(k) (Special)
- Applicant: Jkh Health Co., Ltd.
- Decided: Jul 1, 2020 after 119 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 K940301 (1994). 28 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 31 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 4.
- K141260: Electronic Pulse Stimulator, Shenzhen Jingkehui Electronic Co.., Ltd. (2014) Summary page 4.

## Most influential descendants
- K211942: Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) (2021), 1 descendant of its own
- K223428: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) (2023), 0 descendants of its own

## Indications for use
TENS: PL-029K29, PL-029K30, and PL-029Q 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-029K29, PL-029K30, and PL-029Q) are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS: PL-029K29, PL-029K30, and PL-029Q) 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-029K29, PL-029K30, and PL-029Q are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. Heating: PL-029K30 and PL-029Q is intended for temporary relief of minor aches and pains.

Source page: https://510kreport.com/device/K200561
Methodology: https://510kreport.com/methodology