# Nanowear, Inc.

- Location (FDA's records): Brooklyn, NY
- FDA decisions: 4 (2016–2023): 4 510(k) clearances
- Product codes: DXH (3), DXN (1)
- 510(k) review time since 2016: median 140 days, against 141 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 5 (3 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
- Mega Electronics, Ltd.: 1 (https://510kreport.com/company/mega-electronics)
- Healthwatch, Ltd.: 1 (https://510kreport.com/company/healthwatch)
- Biobeat Technologies, Ltd.: 1 (https://510kreport.com/company/biobeat-technologies)

## Firms that cite its devices most
- Bioserenity Sas: 1 (https://510kreport.com/company/bioserenity)
- Carre Technologies, Inc.: 1 (https://510kreport.com/company/carre-technologies)

## Its most-cited devices
- K201669: SimpleSENSE (2020), cited by 2
- K161431: SimplECG (2016), cited by 2
- K212160: SimpleSENSE Platform (2021), cited by 1

## Recent decisions
- K232053: SimpleSense-BP, SimpleSense-BP Software Application (Dec 8, 2023)
- K212160: SimpleSENSE Platform (Sep 22, 2021)
- K201669: SimpleSENSE (Nov 6, 2020)
- K161431: SimplECG (Nov 30, 2016)

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