# LIH: Interferential Current Therapy

- Device class: 2; regulation: 21 CFR 882.5890; FDA's rule: 510(k) required
- FDA decisions: 73
- 510(k) review time 2021–2025: median 222 days (middle half 206–237)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2005: 2
- 2006: 1
- 2007: 1
- 2009: 2
- 2010: 2
- 2011: 1
- 2012: 2
- 2019: 1
- 2021: 1
- 2024: 1

## Most-cited predicates
- K952683: Apex Medical Corp. Portable Interferential Stimulation Device (1997), cited by 7
- K052289: Deepwave Neuromodulation Pain Therapy Device (2005), cited by 3
- K924961: HMP 4000 Interferential Stimulator (1993), cited by 3
- K032719: GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing) (2003), cited by 3
- K992652: SD-730 IF-SDS, Perfect Pulse IF-SDS (2000), cited by 2
- K930535: IF400 (1994), cited by 2
- K941577: Dynatron 550 (1995), cited by 2
- K930263: Matrix Pro-Elecdt (1994), cited by 1
- K003631: Smartwave IF 2000 (2001), cited by 1
- K952089: Rich-Mar CM-II Combined Muscle Stimulator, Interferential, Tens & Therapeutic Ultrasound Device (1995), cited by 1

Source page: https://510kreport.com/product-code/LIH
Data by year (CSV): https://510kreport.com/product-code/LIH.csv