# Samsung HME America, Inc., dba NeuroLogica Corp.

- Location (FDA's records): Danvers, MA
- FDA decisions: 1 (2026–2026): 1 510(k) clearance
- Product codes: JAK (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Neurologica Corporation, A Subsidiary of Samsung: 1 (https://510kreport.com/company/neurologica-a-subsidiary-of-samsung)
- Neurologica Corporation: 1 (https://510kreport.com/company/neurologica)

## Recent decisions
- K261125: BodyTom 64 (NL4100); OmniTom Elite (NL5000) (Sep 22, 2026)

Source page: https://510kreport.com/company/samsung-hme-america-dba-neurologica