# K112485: H-WAVE

- Pathway: 510(k) (Traditional)
- Applicant: Electronic Waveform Lab, Inc.
- Decided: Dec 6, 2011 after 99 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 K915230 (1992). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813601: E.W.L. P-Tens Model (Tens, Electronic Waveform Laboratory, Inc. (1982) Summary page 1.
- K103738: H-WAVE, Electronic Waveform Laboratory, Inc. (2011) Summary page 1.
- K021496: HMS-DHR-3 Neuromuscular Stimulator, Home Medical Services (2002) Summary page 1.

## Most influential descendants
- K131910: MPP (2014), 1 descendant of its own
- K160255: HBOTC Muscle and Nerve Stimulator (2016), 0 descendants of its own

## Indications for use
The H-Wave® H-4 is indicated for the treatment of chronic pain, acute pain, post-surgical pain, and temporary pain.

Source page: https://510kreport.com/device/K112485
Methodology: https://510kreport.com/methodology