# IRN: Device, Warning, Overload, External Limb, Powered

- Device class: 2; regulation: 21 CFR 890.5575; FDA's rule: 510(k) exempt
- FDA decisions: 11
- 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)
- 1977: 1
- 1979: 1
- 1988: 1
- 1995: 2
- 1996: 3
- 1999: 1
- 2002: 1
- 2006: 1

## Most-cited predicates
- K882974: Force Guard I (1988), cited by 2
- K770405: Overload Warning Device (1977), cited by 1
- K991313: Accutred Shoe (1999), cited by 1
- K023161: Smartstep System (2002), cited by 1
- K955034: Forceguard (1996), cited by 1
- K792241: Pelimit (1979), cited by 1
- K950656: Ped Alert (1995), cited by 1

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