# K081943: Model ES-130

- Pathway: 510(k) (Traditional)
- Applicant: Ito Co., Ltd.
- Decided: Nov 24, 2008 after 139 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). 4 ancestors in all.
7 later devices descend from it; 4 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)
- K051197: Aculife, Model SMW-01, Inno-Health Technology, Inc. (2006) Summary page 1.
- K840983: Pulselife Stimulator, Pulse Life, Inc. (1984) Summary page 1.
- (no number) Model WQ-1IOB: named in the summary without a submission number

## Most influential descendants
- 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
- K200636: AXUS ES-5 Electro-Acupuncture Device (2021), 0 descendants of its own

## Indications for use
The intended use of the ES- 130 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/K081943
Methodology: https://510kreport.com/methodology