# K051197: Aculife, Model SMW-01

- Pathway: 510(k) (Traditional)
- Applicant: Inno-Health Technology, Inc.
- Decided: Mar 28, 2006 after 322 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: 2 generations back to K954334 (1996). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014273: Acustim, S.H.P. Intl. Pty., Ltd. (2002). Our reading of the summary gave K014237, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “ACUSTIM”.

## Most influential descendants
- 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
- K244030: Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (2025), 0 descendants of its own
- K220153: Needle Stimulator (Model: RJNS6-1) (2022), 0 descendants of its own

## Indications for use
The intended use of ACULIFE/Model SMW-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. ACULIFE/model SMW-01 is intended for the stimulation at hands of patient.

Source page: https://510kreport.com/device/K051197
Methodology: https://510kreport.com/methodology