# K180943: BioWaveGO

- Pathway: 510(k) (Traditional)
- Applicant: Biowave Corporation
- Decided: Aug 17, 2018 after 129 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- 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: 1 generation back to K152437 (2015). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152437: BiowaveHOME Neuromodulation Pain Therapy Device, Biowave Corporation (2015) Summary page 5.

## Most influential descendants
- K210202: BioWaveGO  RX (2021), 0 descendants of its own

## Indications for use
The BioWaveGO Neuromodulation Pain Therapy Device is indicated for: - Symptomatic relief of chronic, intractable pain - Symptomatic relief of acute pain - As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

Source page: https://510kreport.com/device/K180943
Methodology: https://510kreport.com/methodology