# K131921: Electronic Pulse Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Jingkehui Electronic Co.., Ltd.
- Decided: Nov 15, 2013 after 142 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 K940301 (1994). 9 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122744: Prospera Otc Tens Electronic Pulse Massager, Prospera Corporation (2013) Summary page 1.

## Most influential descendants
- K141260: Electronic Pulse Stimulator (2014), 5 descendants of its own
- K200561: StimPlus Patch, StimPlus Patch, StimPlus Patch (2020), 2 descendants of its own
- 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
- K182671: Medi-Direct TENS Pen (2019), 0 descendants of its own

## Indications for use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K131921
Methodology: https://510kreport.com/methodology
