# K210202: BioWaveGO  RX

- Pathway: 510(k) (Special)
- Applicant: Biowave Corporation
- Decided: Feb 24, 2021 after 30 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: 2 generations back to K152437 (2015). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180943: BioWaveGO, Biowave Corporation (2018) Summary page 5.

## Indications for use
The BioWaveGO Rx is indicated for prescription use 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/K210202
Methodology: https://510kreport.com/methodology