# Actigraph, LLC

- Location (FDA's records): Pensacola, FL
- FDA decisions: 3 (2008–2023): 3 510(k) clearances
- Names in FDA's records: Actigraph, LLC (2); Actigraph (1)
- Product codes: LEL (2), ISD (1)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 8 (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
- Manufacturing Technology, Inc.: 1 (https://510kreport.com/company/manufacturing-technology)

## Firms that cite its devices most
- Spire, Inc. D/B/A Spire Health: 1 (https://510kreport.com/company/spire-d-b-a-spire-health)
- Arbor Medical Innovations, LLC: 1 (https://510kreport.com/company/arbor-medical-innovations)
- Pneumowave, Ltd.: 1 (https://510kreport.com/company/pneumowave)
- Gkc Manufacturing Pty, Ltd.: 1 (https://510kreport.com/company/gkc-manufacturing)
- Empatica S.r.l.: 1 (https://510kreport.com/company/empatica)
- Sleep Modus, Inc.: 1 (https://510kreport.com/company/sleep-modus)

## Its most-cited devices
- K080545: Actitrainer (2008), cited by 5
- K181077: ActiGraph CentrePoint Insight Watch (2018), cited by 2
- K231532: ActiGraph LEAP activity monitor (ActiGraph LEAP) (2023), cited by 1

## Recent decisions
- K231532: ActiGraph LEAP activity monitor (ActiGraph LEAP) (Jun 23, 2023)
- K181077: ActiGraph CentrePoint Insight Watch (May 24, 2018)
- K080545: Actitrainer (Jul 24, 2008)

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