# PHL: Powered Exoskeleton

- Device class: 2; regulation: 21 CFR 890.3480; FDA's rule: 510(k) required
- FDA decisions: 26
- 510(k) review time 2021–2025: median 185 days (middle half 172–261)
- 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)
- 2017: 2
- 2018: 2
- 2019: 2
- 2020: 4
- 2021: 1
- 2022: 3
- 2023: 2
- 2024: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- K161443: Ekso™ (version 1.1) and Ekso GT™ (version 1.2) (2016), cited by 4
- K173530: Indego (R) (2018), cited by 4
- DEN130034: Rewalk (2014), cited by 3
- K143690: Ekso™ (version 1.1) and Ekso GT™ (version 1.2) (2016), cited by 2
- K152416: Indego (2016), cited by 2
- K181294: Honda Walking Assist Device (2018), cited by 2
- K221696: ReWalk P6.0 (2023), cited by 2
- K200032: ReWalk P6.0 (2020), cited by 1
- K201559: HAL for Medical Use (Lower Limb type) (2020), cited by 1
- K221859: Atalante (2022), cited by 1

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