# K081998: H-Wave Sport

- Pathway: 510(k) (Traditional)
- Applicant: Electronic Waveform Laboratory, Inc.
- Decided: Jul 9, 2009 after 360 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- 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 K940301 (1994). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915230: H Wave Muscle Stimulator, Electronic Waveform Laboratory, Inc. (1992) Summary page 1.
- K011880: Compex Sport, Compex S.A. (2002)

## 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 Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions.

Source page: https://510kreport.com/device/K081998
Methodology: https://510kreport.com/methodology