# IPL: Wheelchair, Standup

- Device class: 2; regulation: 21 CFR 890.3900; FDA's rule: 510(k) required
- FDA decisions: 66
- 510(k) review time 2021–2025: median 394 days (middle half 244–452)
- Recalls: 1 (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)
- 2008: 1
- 2009: 1
- 2010: 2
- 2013: 1
- 2015: 1
- 2018: 2
- 2019: 3
- 2020: 2
- 2022: 2
- 2025: 1

## Most-cited predicates
- K963817: Levo Mobil LCM (1997), cited by 5
- K051387: Levo Comfort II (2005), cited by 4
- K041535: LSC Lifestand Compact (2004), cited by 2
- K083017: LEVO C3 (2008), cited by 2
- K172384: Quickie (r) Q700-UP M (2018), cited by 2
- K030893: Levo Combi (2003), cited by 2
- K031618: Comfort Various of Standing Wheelchair, Hero 2 (2003), cited by 1
- K971873: Levo Active-Easy Lae (1997), cited by 1
- K061726: LSC, Model 3 (2006), cited by 1
- K060936: Paragolfer (2006), cited by 1

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