# K221901: EleGARD

- Pathway: 510(k) (Special)
- Applicant: Advancedcpr Solutions, LLC
- Decided: Jul 29, 2022 after 29 days
- Product code: FOA (Board, Cardiopulmonary)
- Device class: 1
- Regulation: 21 CFR 880.6080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K191689 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191689: EleGARD Patient Positioning System, Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio (2020) Summary page 4.

## Indications for use
The EleGARDTM Patient Positioning System (EleGARD) is a cardiopulmonary board which may elevate a patient's head and thorax: including during airway management; during manual CPR, manual CPR adjuncts, CPR with the LUCAS@ Chest Compression System or ARM XR Automated Chest Compressor; and patient transport. EleGARD is indicated for adults only when used with the LUCAS Chest Compression System or the ARM XR Automated Chest Compressor. When not used with an automated compression system, EleGARD can be used for adults and children, not including infants and neonates.

Source page: https://510kreport.com/device/K221901
Methodology: https://510kreport.com/methodology