# LSB: Unit, Fluidotherapy

- Device class: 2; regulation: 21 CFR 890.5100; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 1987: 1
- 1991: 1
- 2001: 2

## Most-cited predicates
- K871802: Model K210 and K211 Fluidotherapy Units (1987), cited by 1
- K896817: Model T11 Fluidotherapy Unit (1991), cited by 1

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