# K152437: BiowaveHOME Neuromodulation Pain Therapy Device

- Pathway: 510(k) (Special)
- Applicant: Biowave Corporation
- Decided: Sep 25, 2015 after 29 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
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K121478: Nuk Expressivetm Double Electric Breast Pump, Mapa GmbH (2013). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K161154: Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs (2016), 9 descendants of its own
- K170902: Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit (2017), 7 descendants of its own
- K181422: SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit (2018), 6 descendants of its own
- K202660: SPRINT PNS System (2021), 5 descendants of its own
- K213188: Primary Relief (2022), 1 descendant of its own

## Indications for use
The BiowaveHOME Neuromodulation Pain Therapy Device is indicated for: • Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain • Symptomatic relief of acute pain • Symptomatic relief of post-operative pain

Source page: https://510kreport.com/device/K152437
Methodology: https://510kreport.com/methodology