# K091875: E-Pulse

- Pathway: 510(k) (Traditional)
- Applicant: Medevice Corporation
- Decided: Dec 7, 2009 after 167 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K050123: P-Stim System, Neuroscience Therapy Corp. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
E-pulse is an electro-acupundture device for use in the practice of Acupuncture by qualified practitioners of acupuncture as determined by the state.

Source page: https://510kreport.com/device/K091875
Methodology: https://510kreport.com/methodology