# ILJ: Bath, Hydro-Massage

- Device class: 2; regulation: 21 CFR 890.5100; FDA's rule: 510(k) exempt
- FDA decisions: 73
- 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)
- 1995: 2
- 1997: 1
- 1998: 7
- 1999: 1
- 2000: 3
- 2001: 2
- 2004: 1
- 2006: 1
- 2009: 1
- 2011: 1

## Most-cited predicates
- K914125: Ferno Ille HI-LO JR. Mobile Whirlpool, Model 403 (1991), cited by 2
- K964926: Bath Air Spa Fixed Height Hydraulic Operated/Adjustable Height Hydraulic/Fixed Height Electric Reclining/Height Electric (1997), cited by 1
- K930624: Sanitas Whirpool Bathing System (1994), cited by 1
- K904106: Spa Shell (1990), cited by 1
- K923637: Arjo-Century Arm and Leg Tank System (1993), cited by 1
- K883308: Parker Bathing System (1988), cited by 1
- K930665: Century Bathing System (1995), cited by 1
- K001079: Recumbent Bathing Systems, Rhapsody and Primo (2000), cited by 1

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