# Neurometrix, Inc.

- Location (FDA's records): Waltham, MA
- FDA decisions: 18 (1998–2022): 17 510(k) clearances and 1 De Novo grant
- Product codes: JXE (7), GXY (4), GZJ (2), NUH (2), QSQ (1), BXN (1), GWL (1)
- Predicates its devices cite: 34 (22 its own); citations of its devices by later devices: 28 (22 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
- Teca, Inc.: 4 (https://510kreport.com/company/teca)
- Lead-Lok, Inc.: 1 (https://510kreport.com/company/lead-lok)
- Neurotron, Inc.: 1 (https://510kreport.com/company/neurotron)
- Axon Systems, Inc.: 1 (https://510kreport.com/company/axon-systems)
- Mckenna & Cuneo: 1 (https://510kreport.com/company/mckenna-cuneo)
- Axelgaard Mfg. Co., Ltd.: 1 (https://510kreport.com/company/axelgaard-mfg)
- Stockert GmbH: 1 (https://510kreport.com/company/stockert)
- Empi: 1 (https://510kreport.com/company/empi)

## Firms that cite its devices most
- Synapse Electroceutical Limited: 1 (https://510kreport.com/company/synapse-electroceutical)
- Jkh USA, LLC: 1 (https://510kreport.com/company/jkh-usa)
- Mediracer OY: 1 (https://510kreport.com/company/mediracer)
- Carefusion 209, Inc.: 1 (https://510kreport.com/company/carefusion-209)
- Thimble Bioelectronics, Inc.: 1 (https://510kreport.com/company/thimble-bioelectronics)
- Cymedica Orthopedics, Inc.: 1 (https://510kreport.com/company/cymedica-orthopedics)

## Its most-cited devices
- K060584: NC-Stat (2006), cited by 3
- K013459: Modification of NC-Stat (2002), cited by 3
- K982359: NC-Stat (1998), cited by 3
- K000565: Modification to NC-Stat (2000), cited by 3
- K140333: Ascend (2014), cited by 3
- K003508: NC-Stat (2001), cited by 3

## Recent decisions
- DEN210046: Quell-FM (May 18, 2022)
- K152954: Quell (Jan 5, 2016)
- K140586: Ascend Electrode (Nov 17, 2014)
- K140333: Ascend (Jul 3, 2014)
- K130919: Sensus (Jul 2, 2013)
- K121816: Sensus Electrode (Nov 26, 2012)
- K121184: Sensus (Aug 2, 2012)
- K091155: Ascend (Sep 3, 2009)

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