# K141168: Ansistim

- Pathway: 510(k) (Traditional)
- Applicant: Dyansys, Inc.
- Decided: May 15, 2015 after 374 days
- Product code: BWK (Stimulator, Electro-Acupuncture)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954334 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050123: P-Stim System, Neuroscience Therapy Corp. (2006) Summary page 5.

## Indications for use
The ANSiStim™ is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Source page: https://510kreport.com/device/K141168
Methodology: https://510kreport.com/methodology