# K014273: Acustim

- Pathway: 510(k) (Traditional)
- Applicant: S.H.P. Intl. Pty., Ltd.
- Decided: Jun 12, 2002 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
Longest line of descent: 1 generation back to K954334 (1996). 1 ancestor in all.
13 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954334: Acuplus, S.H.P. Intl. Pty., Ltd. (1996) Summary page 4.

## Most influential descendants
- K051197: Aculife, Model SMW-01 (2006), 9 descendants of its own
- K081943: Model ES-130 (2008), 7 descendants of its own
- K130768: Jiajian CMN Stimulator (2013), 3 descendants of its own
- K202861: Needle Stimulator (2021), 2 descendants of its own
- K050123: P-Stim System (2006), 2 descendants of its own

## Indications for use
Etg, |ugtEended use of tho ACUSTIM is for use as an ELECTRO-ACUPUNCTURE it can be used by a Physician administering to his patients,.or by a patient. it is a prescription device and should be used under continued medical supervision. it ick:;as not have curative value but stimulates appropriate auricular acupuncture poin it cannot be used transcerebrally, in the carotid sinus area or during pnegdancy.

Source page: https://510kreport.com/device/K014273
Methodology: https://510kreport.com/methodology