# Neuraxis

- Location (FDA's records): Carmel, IN
- FDA decisions: 4 (2024–2025): 4 510(k) clearances
- Names in FDA's records: Neuraxis (3); Neuraxis, Inc. (1)
- Product codes: QHH (3), KLA (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 2 (2 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
- Innovative Health Solutions (Ihs), Inc.: 1 (https://510kreport.com/company/innovative-health-solutions-ihs)
- Thd Spa: 1 (https://510kreport.com/company/thd)
- Mui Scientific: 1 (https://510kreport.com/company/mui-scientific)

## Its most-cited devices
- K250451: NeurAxis IB-Stim (01-1020) (2025), cited by 1
- K241533: NeurAxis IB-Stim (01-1020) (2024), cited by 1

## Recent decisions
- K252024: NeurAxis IB-Stim (01-1020) (Oct 16, 2025)
- K250451: NeurAxis IB-Stim (01-1020) (May 15, 2025)
- K242304: RED (Dec 6, 2024)
- K241533: NeurAxis IB-Stim (01-1020) (Oct 30, 2024)

Source page: https://510kreport.com/company/neuraxis