# K103738: H-WAVE

- Pathway: 510(k) (Special)
- Applicant: Electronic Waveform Laboratory, Inc.
- Decided: Jun 1, 2011 after 161 days
- Product code: IPF (Stimulator, Muscle, Powered)
- 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: 1 generation back to K915230 (1992). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 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.

## Most influential descendants
- K112485: H-WAVE (2011), 2 descendants of its own
- 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® is indicated for the following conditions: 1. Relaxation of muscle spasms; 2. Prevention or retardation of disuse atrophy; 3. Increasing local blood circulation; 4. Muscle re-education; 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and 6. Maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K103738
Methodology: https://510kreport.com/methodology