# Pivotal Health Solutions

- Location (FDA's records): Watertown, SD
- FDA decisions: 2 (2010–2014): 2 510(k) clearances
- Product codes: ITH (2)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- The Saunders Group: 1 (https://510kreport.com/company/saunders-group)
- Chattanooga Group, Inc.: 1 (https://510kreport.com/company/chattanooga-group)
- Circular Traction Supply, Inc.: 1 (https://510kreport.com/company/circular-traction-supply)

## Recent decisions
- K131983: Itrac Cervical Traction System (Sep 10, 2014)
- K101889: Decompression of Choice and Neuro Decompression Device (Aug 27, 2010)

Source page: https://510kreport.com/company/pivotal-health-solutions