# K172834: Dual output digital therapy massager

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Osto Technology Co., Ltd.
- Decided: Sep 6, 2018 after 352 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K940301 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133929: Health Expert Elctronic Stimulator, Shenzhen Osto Technology Company Limited (2014) Summary page 4.

## Indications for use
PMS (Mode 1) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 2) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Source page: https://510kreport.com/device/K172834
Methodology: https://510kreport.com/methodology